MAUDE Adverse Event Report: SHIRE-BAXALTA US ADVATE BAXJECT III; SET, I.V. FLUID TRANSFER

Model Number BAXJECT III

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

Details: a single system complaint was received from a customer in the us reporting that baxject iii systems after from lot tanr024ca.Analysis of the sample showed that a single finger from the trigger assembly had pre-released and made contact with and penetrated part of the crimps of the swfi vials.The user was able to apply enough force to the baxject iii to fully seat the swfi vial, and cause the trigger assembly to fracture and fully spike the product vial.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.An investigation into the pre-release of triggers in the baxject iii system was conducted and documented in special report (b)(4) under capa pr# (b)(4) in september, 2015.Several potential failure modes for pre-release of the plastic triggers were identified in both the baxject iii sub-assembly process at the supplier (baxter healthcare, (b)(4)) and the final drug product system assembly process at (b)(4).Several corrective actions have been implemented at baxter (b)(4) and at the (b)(4) manufacturing site.Failure analysis concluded a probable root cause of triggers being released during the bjiii assembly process due to angular insertion at station 100.Trend event pr# (b)(4) has been open for the trend in trigger pre-releases and additional investigation will be conducted under that capa.Product impact: the pre-release of the trigger would typically not allow the spike to penetrate the stopper, and therefore reconstitution is not possible.The patient would not be able to recover the drug product from the system and would need to use another system.Patient impact or potential adverse health impact: no impact to patient safety as the dosage was not used and a replacement was available in every case.

Event Description

Advate with the baxject iii(bjiii) reconstitution system consists of a vial lyophilized drug product (advate) and a vial of sterile water for injection (swfi) for use as a diluent, which are packed in a spiked sleeve to facilitate reconstitution and administration.During the period of (b)(6) 2017, 4 complaints have been received in which the patient/caregiver was unable to reconstitute the advate product using the baxject iii reconstitution system.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.The individual events were not reported because there was no death or serious injury, nor would that be likely if the defect were to reoccur due to patient discarding the product and uses a new one, so in all cases there are always availability of additional product to the patients.However, (b)(6) made a decision to report these events and inform cdrh that we recognize this as a recurring minor defect and that an investigation is in progress and any appropriate corrective actions will be taking to prevent recurrence.

Manufacturer Narrative

Details: a single system complaint was received from a customer in the us reporting that baxject iii systems after from lot tanr024ca.Analysis of the sample showed that a single finger from the trigger assembly had pre-released and made contact with and penetrated part of the crimps of the swfi vials.The user was able to apply enough force to the baxject iii to fully seat the swfi vial, and cause the trigger assembly to fracture and fully spike the product vial.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.An investigation into the pre-release of triggers in the baxject iii system was conducted and documented in special report (b)(4) under capa pr# (b)(4) in (b)(6) 2015.Several potential failure modes for pre-release of the plastic triggers were identified in both the baxject iii sub-assembly process at the supplier ((b)(4)) and the final drug product system assembly process at (b)(4).Several corrective actions have been implemented at baxter (b)(4) and at the (b)(4) manufacturing site.Failure analysis concluded a probable root cause of triggers being released during the bjiii assembly process due to angular insertion at station 100.Trend event pr# (b)(4) has been open for the trend in trigger pre-releases and additional investigation will be conducted under that capa.Product impact: the pre-release of the trigger would typically not allow the spike to penetrate the stopper, and therefore reconstitution is not possible.The patient would not be able to recover the drug product from the system and would need to use another system.Patient impact or potential adverse health impact: no impact to patient safety as the dosage was not used and a replacement was available in every case.Additional complaint received and an update to current investigation ((b)(6) 2017): on aug 31, 2017, a complaint sample evaluation (pr (b)(4) ) for advate with baxject iii reconstitution system lot # tavr030ba was completed and confirmed as another pre-released trigger finger defect.This is the same defect as reported in this mdr (2032282-2017-07271) on july 13, 2017.The trend in pre-released trigger defects is being investigated under capa pr# (b)(4).When this defect occurs, one of the three trigger fingers is pushed into the diluent vial crimp cap, causing it to bend, break, and or penetrate the crimp.Investigation revealed that this is due to the other two trigger fingers being dislodged from their respective diluent sleeve notch.The most probable root cause identified for the other two trigger fingers being dislodged has been determined to be misalignment of the product vial during automated insertion into the baxject iii subassembly.Identification of corrective actions to address this issue are in progress.There continues to be no impact to patient safety as a result of these defects.Updated health hazard evaluation completed and attached.Updates to capa pr#(b)(4) (20 nov 2017): root cause analysis has been identified as inadequate design of equipment in the baxject iii assembly process.Corrective actions have been initiated to upgrade the bjiii assembly line to address the issues.The changes to be completed include: station 30/40/90 upgrades (decapping stations): unclamp the product vial after flip cap removal to allow the vial to be properly seated inside the nest before it gets to station 100.Implement a new fixture concept for the station 90 flip cap removal fixture.Replace the flip cap removal fixture at both the ph swfi and cl swfi flip cap removal stations.Removal of pneumatic clamping at station 100a : software change to remove pneumatic clamping and have spring-loaded clamping.Force monitoring at station 100 : add force monitoring (load cell) at station 100 (similar to what is done at station 100a).Trigger skirt unevenness inspection : optimize the inspection process for the trigger skirt to be able to reliably detect an uneven trigger skirt 360 degrees with three (3) sensors to cover perimeter.Station 100 alignment/debug: lower the retracted position at the pedestal mount.There continues to be no impact to patient safety as a result of these defects.

Event Description

Advate with the baxject iii(bjiii) reconstitution system consists of a vial lyophilized drug product (advate) and a vial of sterile water for injection (swfi) for use as a diluent, which are packed in a spiked sleeve to facilitate reconstitution and administration.During the period of 03/28/17 to 06/01/17, 4 complaints have been received in which the patient/caregiver was unable to reconstitute the advate product using the baxject iii reconstitution system.This is the 10th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.The individual events were not reported because there was no death or serious injury, nor would that be likely if the defect were to reoccur due to patient discarding the product and uses a new one, so in all cases there are always availability of additional product to the patients.However, shire made a decision to report these events and inform cdrh that we recognize this as a recurring minor defect and that an investigation is in progress and any appropriate corrective actions will be taking to prevent recurrence.

Manufacturer Narrative

Details: a single system complaint was received from a customer in the us reporting that baxject iii systems after from lot tanr024ca analysis of the sample showed that a single finger from the trigger assembly had pre-released and made contact with and penetrated part of the crimps of the swfi vials.The user was able to apply enough force to the baxject iii to fully seat the swfi vial, and cause the trigger assembly to fracture and fully spike the product vial.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.An investigation into the pre-release of triggers in the baxject iii system was conducted and documented in special report (b)(4) under capa pr# 955922 in september, 2015.Several potential failure modes for pre-release of the plastic triggers were identified in both the baxject iii sub-assembly process at the supplier (baxter healthcare, cleveland mississippi) and the final drug product system assembly process at thousand oaks.Several corrective actions have been implemented at baxter cleveland and at the thousand oaks manufacturing site.Failure analysis concluded a probable root cause of triggers being released during the bjiii assembly process due to angular insertion at station 100.Trend event (b)(4) has been open for the trend in trigger pre-releases and additional investigation will be conducted under that capa.Product impact: the pre-release of the trigger would typically not allow the spike to penetrate the stopper, and therefore reconstitution is not possible.The patient would not be able to recover the drug product from the system and would need to use another system.Patient impact or potential adverse health impact: no impact to patient safety as the dosage was not used and a replacement was available in every case.Additional complaint received and an update to current investigation (25 september 2017): on aug 31, 2017, a complaint sample evaluation ((b)(4)) for advate with baxject iii reconstitution system lot # tavr030ba was completed and confirmed as another pre-released trigger finger defect.This is the same defect as reported in this mdr (2032282-2017-07271) on july 13, 2017.The trend in pre-released trigger defects is being investigated under capa (b)(4).When this defect occurs, one of the three trigger fingers is pushed into the diluent vial crimp cap, causing it to bend, break, and or penetrate the crimp.Investigation revealed that this is due to the other two trigger fingers being dislodged from their respective diluent sleeve notch.The most probable root cause identified for the other two trigger fingers being dislodged has been determined to be misalignment of the product vial during automated insertion into the baxject iii subassembly.Identification of corrective actions to address this issue are in progress.There continues to be no impact to patient safety as a result of these defects.Updated health hazard evaluation completed and attached.Updates to capa pr#1221295 (20 nov 2017): root cause analysis has been identified as inadequate design of equipment in the baxject iii assembly process.Corrective actions have been initiated to upgrade the bjiii assembly line to address the issues.The changes to be completed include: 1) station 30/40/90 upgrades (decapping stations): unclamp the product vial after flip cap removal to allow the vial to be properly seated inside the nest before it gets to station 100.Implement a new fixture concept for the station 90 flip cap removal fixture.Replace the flip cap removal fixture at both the ph swfi and cl swfi flip cap removal stations.2) removal of pneumatic clamping at station 100a: software change to remove pneumatic clamping and have spring-loaded clamping.3) force monitoring at station 100: add force monitoring (load cell) at station 100 (similar to what is done at station 100a).4) trigger skirt unevenness inspection: optimize the inspection process for the trigger skirt to be able to reliably detect an uneven trigger skirt 360 degrees with three (3) sensors to cover perimeter.5) station 100 alignment/debug: lower the retracted position at the pedestal mount.There continues to be no impact to patient safety as a result of these defects.Update: this report is follow-up #2 but it was inadvertently numbered as follow-up #3 in error.

Event Description

Advate with the baxject iii(bjiii) reconstitution system consists of a vial lyophilized drug product (advate) and a vial of sterile water for injection (swfi) for use as a diluent, which are packed in a spiked sleeve to facilitate reconstitution and administration.During the period of 03/28/17 to 06/01/17, 4 complaints have been received in which the patient/caregiver was unable to reconstitute the advate product using the baxject iii reconstitution system.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.The individual events were not reported because there was no death or serious injury, nor would that be likely if the defect were to reoccur due to patient discarding the product and uses a new one, so in all cases there are always availability of additional product to the patients.However, shire made a decision to report these events and inform cdrh that we recognize this as a recurring minor defect and that an investigation is in progress and any appropriate corrective actions will be taking to prevent recurrence.

Event Description

Advate with the baxject iii(bjiii) reconstitution system consists of a vial lyophilized drug product (advate) and a vial of sterile water for injection (swfi) for use as a diluent, which are packed in a spiked sleeve to facilitate reconstitution and administration.During the period of 03/28/17 to 06/01/17, 4 complaints have been received in which the patient/caregiver was unable to reconstitute the advate product using the baxject iii reconstitution system.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.The individual events were not reported because there was no death or serious injury, nor would that be likely if the defect were to reoccur due to patient discarding the product and uses a new one, so in all cases there are always availability of additional product to the patients.However, shire made a decision to report these events and inform cdrh that we recognize this as a recurring minor defect and that an investigation is in progress and any appropriate corrective actions will be taking to prevent recurrence.

Manufacturer Narrative

Details: a single system complaint was received from a customer in the us reporting that baxject iii systems after from lot tanr024ca analysis of the sample showed that a single finger from the trigger assembly had pre-released and made contact with and penetrated part of the crimps of the swfi vials.The user was able to apply enough force to the baxject iii to fully seat the swfi vial, and cause the trigger assembly to fracture and fully spike the product vial.This is the 9th confirmed complaint for a pre-released trigger assembly for advate with baxject iii.There is no correlation between complaint lots.An investigation into the pre-release of triggers in the baxject iii system was conducted and documented in special report 75966sr under capa pr# 955922 in september, 2015.Several potential failure modes for pre-release of the plastic triggers were identified in both the baxject iii sub-assembly process at the supplier (baxter healthcare, (b)(6) ) and the final drug product system assembly process at thousand oaks.Several corrective actions have been implemented at baxter cleveland and at the thousand oaks manufacturing site.Failure analysis concluded a probable root cause of triggers being released during the bjiii assembly process due to angular insertion at station 100.Trend event (b)(4) has been open for the trend in trigger pre-releases and additional investigation will be conducted under that capa.Product impact: the pre-release of the trigger would typically not allow the spike to penetrate the stopper, and therefore reconstitution is not possible.The patient would not be able to recover the drug product from the system and would need to use another system.Patient impact or potential adverse health impact: no impact to patient safety as the dosage was not used and a replacement was available in every case.Additional complaint received and an update to current investigation (25 september 2017): on aug 31, 2017, a complaint sample evaluation ((b)(4)) for advate with baxject iii reconstitution system lot # tavr030ba was completed and confirmed as another pre-released trigger finger defect.This is the same defect as reported in this mdr (2032282-2017-07271) on july 13, 2017.The trend in pre-released trigger defects is being investigated under capa pr# 1221295.When this defect occurs, one of the three trigger fingers is pushed into the diluent vial crimp cap, causing it to bend, break, and or penetrate the crimp.Investigation revealed that this is due to the other two trigger fingers being dislodged from their respective diluent sleeve notch.The most probable root cause identified for the other two trigger fingers being dislodged has been determined to be misalignment of the product vial during automated insertion into the baxject iii subassembly.Identification of corrective actions to address this issue are in progress.There continues to be no impact to patient safety as a result of these defects.Updated health hazard evaluation completed and attached.Update: this report is follow-up #1 but it was inadvertently numbered as follow-up #2 in error.

• Brand Name: ADVATE BAXJECT III
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SHIRE-BAXALTA US; 1455 lawrence drive; thousand oak CA 91320
• MDR Report Key: 7015034
• MDR Text Key: 184051298
• Report Number: 2032282-2017-07271
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: BAXJECT III
• Device Catalogue Number: ADVATE
• Device Lot Number: TANR024CA;TAVR030BA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Was the Report Sent to FDA?: No
• Device Age: 1 YR
• Event Location: Outpatient Treatment Facility
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 08/10/2017; 08/10/2017; 08/10/2017
• Supplement Dates FDA Received: 02/28/2020; 02/28/2020; 11/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1