MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381867

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7037934, medical device expiration date: 2020-01-31, device manufacture date: 2017-02-10; medical device lot #: 7138793, medical device expiration date: 2020-04-30, device manufacture date: 2017-05-18; medical device lot #: 5308745 medical, device expiration date: 2018-10-31, device manufacture date: 2015-11-04; medical device lot #: 4318680, medical device expiration date: 2017-11-30, device manufacture date: 2014-11-14.Investigation: the corrective action statement is approved/authorized and final review of the complaint will be conducted by designated complaint handling unit.Complaint: package seal integrity poor-questionable.Event description: the package weren¿t sealed.Lot analysis: device/batch history record review: yes.Findings: lot 7037934: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from feb 15, 2017 through june 6, 2017 (stopped and re-started).Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Lot 7138793: a total of (b)(4) units were built on afa line 6 from 26may2017 through 6jul2017 and packaged on pkg line 11 and line 8 from 6jul2017 through 7jul2017.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Lot 4318680: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from nov 19, 2014 through nov 28, 2014.Per review of the dhr, it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Lot 5308734: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from nov 7, 2015 through nov 28, 2015.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.(b)(4) was issued to temporarily reduce the allowable range of several sealing parameters in order to investigate the raw material issue related to the compromised seal.Qn / sap database review: no.Reason: a review of the qn/sap database is not required for a s1 - o1 level a.Investigation per (b)(4).Visual analysis: observations and testing: received a total of (b)(4) unused iag 14ga units as follows: (b)(4) units from lot number 7037934, (b)(4) units from lot number 7138793, (b)(4) units from lot number 5308745 and (b)(4) units from lot number 4318680.Visual/microscopic examination: lot 7037934: (b)(4) units were partially open at one end.(b)(4) units were partially open at both ends.(b)(4) units were not open.Lot 7138793: (b)(4) units were partially open at one end.(b)(4) units were not open.Lot 5308745: (b)(4) units were partially open at one end.(b)(4) units were partially open at both ends.(b)(4) unit was not open.Lot 4318680: (b)(4) units were partially open at one end.(b)(4) units were partially open at both ends.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition the paper top web of the returned unit was analyzed under uv light.The glue used to seal the top and bottom webs is uv fluorescent.The analysis revealed an adequate of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were looked at during the investigation.Test description: visual/uv light ; method no.:n/a; results: see observations and testing.Investigation samples(s) meet manufacturing specifications: yes; the returned units provided for evaluation for this incident met the manufacturing specification requirements.Conclusions: the defect of package damaged, as stated in the subject of the pir was confirmed with the returned units.Even though the packages came partially opened, all the processes characteristics that directly influence the seal strength are: seal transfer and top web glue, measured within specification.No anomalies were found.Did the evaluation confirm the customer's experience with the bd product? yes; the customer experienced was confirmed based on the evaluation that was performed on the returned units.Were we able to reproduce the customer's experience with the bd product? no; it was not necessary to achieve reproduction of the customer¿s experience, as the defect was confirmed.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate.Comment: the packaging operators are responsible to verify the seal transfer/width and that packages are ¿water leak tested¿ every hour.These attribute inspections are done to verify that the packages are sealed adequately prior to placing them within the dispenser.This is issue is currently being investigated by capa (b)(4).Corrections and capa corrective action / capa #: (b)(4) has been opened to address the package seal integrity issue.Other actions taken (if applicable): packaging operators are responsible to verify package integrity, including the verification that the packages are adequately sealed.In addition, product quality is evaluated during the manufacturing and packaging process with prescribed attributes inspections.These inspections are performed by operators to ensure any gross process changes are identified.If defects are observed, disposition of the product, root cause and corrective action(s) are applied according to the quality control plan.

Event Description

It was reported that the packages of the bd insyte¿ autoguard¿ shielded iv catheter were not sealed.There was no report of injury or medical intervention.

Manufacturer Narrative

Lot analysis: findings: lot 7037934: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from feb 15, 2017 through june 6, 2017 (stopped and re-started).Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Lot 7138793: a total of (b)(4) units were built on afa line 6 from 26may17 through 6jul17 and packaged on pkg line 11 and line 8 from 6jul17 through 7jul17.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Lot 4318680: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from nov 19, 2014 through nov 28, 2014.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Lot 5308734: a total of (b)(4) units were built on afa line 6 and packaged on pkg line 11 from nov 7, 2015 through nov 28, 2015.Per review of the dhr it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.In process samples (included but not limited) blister thickness, bad seal/cut/holes, seal transfer width and package leak test were performed on various stages throughout the process, all the inspections passed per specifications.Td # (b)(4) (engineering study (b)(4)) was issued to temporarily reduce the allowable range of several sealing parameters in order to investigate the raw material issue related to the compromised seal.Visual analysis: observations and testing: received a total of 98 unused iag 14ga units as follows: 75 units from lot number 7037934, 6 units from lot number 7138793, 12 units from lot number 5308745 and 5 units from lot number 4318680.Visual/microscopic examination: 33 units were partially open at one end.39 units were partially open at both ends.3 units were not open.Lot 7138793: 2 units were partially open at one end.4 units were not open.Lot 5308745: 2 units were partially open at one end.9 units were partially open at both ends.1 unit was not open.Lot 4318680: 2 units were partially open at one end.3 units were partially open at both ends.The analysis of top web adhesive: the product characteristics require a minimum of 1/8¿ seal transfer.This characteristic was met.In addition the paper top web of the returned unit was analyzed under uv light.The glue used to seal the top and bottom webs is uv fluorescent.The analysis revealed an adequate of top web adhesive.The key variables that affect seal strength are: seal transfer/width and top web glue.Both of these variables were looked at during the investigation.Test description: method no.: results: visual/uv light, n/a, see observations and testing.Investigation samples(s) meet manufacturing specifications: yes; the returned units provided for evaluation for this incident met the manufacturing specification requirements.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7097074
• MDR Text Key: 95065072
• Report Number: 1710034-2017-00436
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381867
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/07/2017
• Supplement Dates Manufacturer Received: 11/13/2017
• Supplement Dates FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other