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	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with 2 bd phaseal¿ protector p14 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: when sampling for product 515100 - when the product was sampled and then returned to the field a leak occurred.
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
H6: investigation summary : no photos or physical samples that display the reported issue were provided for investigation.A device history review was performed for reported lot 2209119, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.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, no leakages between the protector and vial or any other components were observed, and the product functioned as intended.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device, all records were reviewed for the reported lot and results were found to be acceptable.Based on our quality team's investigation, we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that during use with 2 bd phaseal¿ protector p14 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: when sampling for product 515100 - when the product was sampled and then returned to the field a leak occurred.

• 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 ; 8448235433
• MDR Report Key: 16482225
• Report Number: 3003152976-2023-00041
• Device Sequence Number: 7671784
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2023

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: 2209119
• 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: 02/06/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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