MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR (P13-O); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515060
Medical Device Problem Codes	Volume Accuracy Problem (1675); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that flow issues occurred during use with a bd phaseal optima protector (p13-o).The following information was provided by the initial reporter, "this complaint pertains to the dosage inaccuracies reported when using the injector/protector.Material no.515060, batch no.1908105.It was reported that is was difficult to disengage."information learned from lead pharmacy technician representing eight pharmacy technicians during the 30 day post optima cstd conversion meeting.Background: site began using phaseal, (b)(6) 2010.No voiced or documented ergonomic concerns with using phaseal.Preparations volume: 85 pts.A day at 2.5 doses averaged per patient.This was quoted by pharmacist manager = 212 doses a day or 552, 50 doses a year.Lead pharmacy technician detailed the ergonomic concern when moving from phaseal to optima (b)(6) 2019.Difficult to disengage injectors from protector, injectors from infusion adapter resulting in experiencing sore shoulders and neck and thumbs.Degree of difficulty to disengage noticeable more than when preparing with phaseal verbalized by all nine pharmacy technicians.All pharmacy technicians have mentioned the difficulty to disengage and with repetitive preparations resulting in soreness during and at end of day.All pharmacy technicians mentioned the degree of soreness, was not displayed when working with bd phaseal at the end or during the day.Product performance: with most syringes but mostly using the 50 cc syringe with optima.The desired dose was withdrawn with injectors / protector in upright, position then vial placed flat on surface biological safety cabinet to disengage.The result a miss with the volumes of desired dose.I asked how the injectors to protector disengagement was occurring and the answers were upright, also vial flat to surface and vial horizontal to surface.I asked to better understand the techniques, when using phaseal injectors/protector unit disengaged from vial, when vial was flat to surface or vial upright resulting i resulting desired drug volume in syringe.The pharmacy technician stated it "with this steps using optima the desired drug is visualized however the volumes shift to less than what was visualized when the injectors and protector unit are disengaged.Result going back-into vial to withdraw the desired hd dose, so extra steps used when preparing with optima versus phaseal.".
Event or Problem Description
It was reported that flow issues occurred during use with a bd phaseal optima protector (p13-o).The following information was provided by the initial reporter, "this complaint pertains to the dosage inaccuracies reported when using the injector/protector material no.515060 batch no.1908105 it was reported that is was difficult to disengage."information learned from lead pharmacy technician representing eight pharmacy technicians during the 30 day post optima cstd conversion meeting background: site began using phaseal , november 2010 no voiced or documented ergonomic concerns with using phaseal preparations volume : 85 pts.A day at 2.5 doses averaged per patient this was quoted by pharmacist manager = 212 doses a day or 552, 50 doses a year.Lead pharmacy technician detailed the ergonomic concern when moving from phaseal to optima december, 2019 difficult to disengage injectors from protector, injectors from infusion adapter resulting in experiencing sore shoulders and neck and thumbs.Degree of difficulty to disengage noticeable more than when preparing with phaseal verbalized by all all nine pharmacy technicians.All pharmacy technicians have mentioned the difficulty to disengage and with repetitive preparations resulting in soreness during and at end of day all pharmacy technicians mentioned the degree of soreness, was not displayed when working with bd phaseal at the end or during the day product performance: with most syringes but mostly using the 50 cc syringe with optima the desired dose was withdrawn with injectors / protector in upright, position then vial placed flat on surface biological safety cabinet to disengage.Rthe result a miss with the volumes of desired dose.I asked how the injectors to protector disengagement was occurring and the answers were upright, also vial flat to surface and vial horizontal to surface.I asked to better understand the techniques , when using phaseal injectors/protector unit disengaged from vial, when vial was flat to surface or vial upright resulting i resulting desired drug volume in syringe.The pharmacy technician stated it "with this steps using optima the desired drug is visualized however the volumes shift to less than what was visualized when the injectors and protector unit are disengaged., result going back-into vial to withdraw the desired hd dose, so extra steps used when preparing with optima versus phassal.".
Additional Manufacturer Narrative
The following fields have been updated due to corrected information: event problem code: 1675.
Event or Problem Description
It was reported that flow issues occurred during use with a bd phaseal optima protector (p13-o).The following information was provided by the initial reporter, "this complaint pertains to the dosage inaccuracies reported when using the injector/protector material no.515060 batch no.1908105.It was reported that is was difficult to disengage.
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1908105, no deviations or non-conformances related to this issue were identified during the manufacturing process.Testing is performed throughout manufacturing according to procedure, including flow rate and leakage testing here machines detect any blockages.Results were review for the reported lot and all results were within required specifications.Four retained samples of the same lot were used for additional evaluation.Functional testing was performed and in all cases flow was observed and the product functioned as intended.Based on the available information we are not able to determine a root cause at this time.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that flow issues occurred during use with a bd phaseal optima protector (p13-o).The following information was provided by the initial reporter, "this complaint pertains to the dosage inaccuracies reported when using the injector/protector material no.515060 batch no.1908105 it was reported that is was difficult to disengage."information learned from lead pharmacy technician representing eight pharmacy technicians during the 30 day post optima cstd conversion meeting background: site began using phaseal , november 2010 no voiced or documented ergonomic concerns with using phaseal preparations volume : 85 pts.A day at 2.5 doses averaged per patient this was quoted by pharmacist manager = 212 doses a day or 552, 50 doses a year.Lead pharmacy technician detailed the ergonomic concern when moving from phaseal to optima december, 2019 difficult to disengage injectors from protector, injectors from infusion adapter resulting in experiencing sore shoulders and neck and thumbs.Degree of difficulty to disengage noticeable more than when preparing with phaseal verbalized by all all nine pharmacy technicians.All pharmacy technicians have mentioned the difficulty to disengage and with repetitive preparations resulting in soreness during and at end of day all pharmacy technicians mentioned the degree of soreness, was not displayed when working with bd phaseal at the end or during the day product performance: with most syringes but mostly using the 50 cc syringe with optima the desired dose was withdrawn with injectors / protector in upright, position then vial placed flat on surface biological safety cabinet to disengage.The result a miss with the volumes of desired dose.I asked how the injectors to protector disengagement was occurring and the answers were upright, also vial flat to surface and vial horizontal to surface.I asked to better understand the techniques , when using phaseal injectors/protector unit disengaged from vial, when vial was flat to surface or vial upright resulting i resulting desired drug volume in syringe.The pharmacy technician stated it "with this steps using optima the desired drug is visualized however the volumes shift to less than what was visualized when the injectors and protector unit are disengaged., result going back-into vial to withdraw the desired hd dose, so extra steps used when preparing with optima versus phassal.".
Additional Manufacturer Narrative
Mfr# (b)(4) after further evaluation is deemed to be not reportable.Inadequate pressure equalization related to user error resulting in negative pressure inside the syringe can result in reduced volume inside they syringe.This would be an inconvenience as an additional step would be required to obtain the remaining medication but not would not lead to harm or serious injury.As a result this mfr# is void.

• Brand Name: BD PHASEAL OPTIMA PROTECTOR (P13-O)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9891973
• Report Number: 3003152976-2020-00147
• Device Sequence Number: 13613975
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: 00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 515060
• Device Lot Number: 1908105
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020; 01/15/2020; 01/15/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 03/30/2020; 04/03/2020; 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other