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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd phaseal¿ protector p14 leaked from the expansion chamber during use.The following information was provided by the client: "phaseal protector p14 leaked from the expansion chamber, 3rd incident with this item, same lot no.Exposure to live virus (bcg).".
Additional Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 2109117, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.During manufacturing, leakage testing is performed to ensure the quality of the membrane.Testing was reviewed for lot 2109117, all results were found to be within specification.Five retained samples of the same lot were used for additional evaluation.Functional testing was performed, connecting the protector sample to both a vial, injector, and syringe per the instructions for use provided with the product.In all cases, liquid could be drawn from the vial without issue and no leakages were observed.Based on our quality team's investigation and the provided information, it appears the reported incident was related to improper connection of the protector onto the vial.The protector must be attached completely vertical to the vial.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 leaked from the expansion chamber during use.The following information was provided by the client: "phaseal protector p14 leaked from the expansion chamber, 3rd incident with this item, same lot no.Exposure to live virus (bcg)".

• 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: 14435513
• Report Number: 3003152976-2022-00221
• Device Sequence Number: 5758737
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 515100
• Device Lot Number: 2109117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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