MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P14); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that oncotice leaked from the between the bd phaseal¿ protector (p14) and vial after being reconstituted.The following information was provided by the initial reporter: "oncotice leaked from vial after reconstitution.Phaseal p14 protector placed on vial.45ml of saline was drawn into 50ml syringe from saline bag using blunt tip needle.Needle was discarded and phaseal injector was placed on 50ml syringe.50ml syringe with injector was engaged with protector and vial.2-3ml of saline pushed into vial.Drug was gently swirled.Vial was inverted to be aspirated.Drug started leaking from the vial (at the protector and vial connection).".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-jan-2023.H6: investigation summary two protectors assembled onto a vial and two injectors, were provided to our quality team for investigation.Upon initial inspection, there was no visible damage or defects with any of the product.Functional testing was performed, and although there was no fluid within either vial to evaluate leakage, the expansion chamber was found to properly inflate in both samples.The injectors were disassembled for further evaluation and no obstructions with found within the device that would prevent the flow of liquid.Upon inspection of the protectors, it was found that the protectors were assembled on to the vial incorrectly.The needle of the protector punctured the vial stopper off center, puncturing part of the metal ring that grips the vial stopper.A device history review was performed for protector lot 2205101 and injector lot lot 2203007, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained protectors and injectors of the same lot were used for additional testing.Functional testing was performed, connecting the protector samples to a vial, injector, and syringe per the instructions for use provided with the product.In all cases liquid was able to be drawn from the vial without issue, no leakage occurred, and the product functioned as intended.Based on our quality team's investigation and sample evaluation, it was determined this incident was due to the protectors being improperly assembled, causing the leakage as well as preventing the product from properly drawing the liquid from the vial.
Event or Problem Description
It was reported that oncotice leaked from the between the bd phaseal¿ protector (p14) and vial after being reconstituted.The following information was provided by the initial reporter: "oncotice leaked from vial after reconstitution - phaseal p14 protector placed on vial - 45ml of saline was drawn into 50ml syringe from saline bag using blunt tip needle - needle was discarded and phaseal injector was placed on 50ml syringe - 50ml syringe with injector was engaged with protector and vial - 2-3ml of saline pushed into vial - drug was gently swirled - vial was inverted to be aspirated - drug started leaking from the vial (at the protector and vial connection)".

• Brand Name: BD PHASEAL¿ PROTECTOR (P14)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15686513
• Report Number: 3003152976-2022-00485
• Device Sequence Number: 6822288
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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
• Operator of Device: Other
• Device Catalogue Number: 515100
• Device Lot Number: 2205101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 02/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown