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

Model Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 leakage occured.The following information was provided by the initial reporter, translated from french to english: leakage of chemo product through the device.
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 sample or photo received by our quality team for investigation.A device history review was performed for reported lot 2210110 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no defects or issues observed.Functional testing was performed, liquid inside the syringe could move to the vial and back to the syringe without issue and no leaks were observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.Further testing was conducted and after properly reconnecting the vial and protector, no sign of leakage occurred.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.H3 other text : see h10.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 leakage occured.The following information was provided by the initial reporter, translated from french to english: leakage of chemo product through the device.

• 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: 16653032
• Report Number: 3003152976-2023-00110
• Device Sequence Number: 6521636
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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 Model Number: 515100
• Device Catalogue Number: 515100
• Device Lot Number: 2210110
• 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: 03/10/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2022
• 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