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	06/24/2022
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 experienced leakage.The following information was provided by the initial reporter: customer continues to have issues with p-14 protectors not operating correctly.Sometimes chemo leaks from the deice.
Additional Manufacturer Narrative
Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 2201139, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or defects were observed.Functional testing was performed, connecting the protectors to a vial using the m12 assembly fixture, then to an injector and syringe per the instructions for use provided with the product.In all cases liquid was able to be drawn from the vial, the expansion chamber properly expanded, no leakage into the expansion chamber or between the protector and vial was observed, and the product functioned as intended.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.These tests include visual inspections along with leakage testing, flow rate, and verification of the proper placement and function of the expansion chamber.All records were reviewed for the reported lot and results were found to be acceptable.Based on the available information we are not able to determine a root cause at this time.H3 other text : see h10.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 experienced leakage.The following information was provided by the initial reporter: customer continues to have issues with p-14 protectors not operating correctly.Sometimes chemo leaks from the deice.

• 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: 15118022
• Report Number: 3003152976-2022-00335
• Device Sequence Number: 7329417
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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 Catalogue Number: 515100
• Device Lot Number: 2201139
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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