MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515105
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that protector p50 filter came loose.The following information was provided by the initial reporter: hydrofobic filter came loose of the protector cap.When did the incident occur? before use hydrofobic filter came loose of the protector cap when air was pushed into the balloon.
Event or Problem Description
It was reported that protector p50 filter came loose.The following information was provided by the initial reporter: hydrofobic filter came loose of the protector cap.When did the incident occur? before use hydrofobic filter came loose of the protector cap when air was pushed into the balloon.
Additional Manufacturer Narrative
H6: investigation summary: one sample was provided to our quality team for investigation.After visual inspection, the filter cover was observed to be incorrectly welded, one filter cover was identified to be joined over another.A device history review was performed for reported lot 2006138, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device, including verification the filter is properly placed and welded, automatically rejecting any defective product identified.All records were reviewed for the reported lot and results were found to be acceptable, no issues related to this incident were found.The detection system was challenged by placing the sample in the equipment and in all cases, the sample was properly discarded by the detection system.It is possible a blockage in the assembly machine lead to both filters being welded to the expansion bladder improperly, however, no maintenance order or other non-conformances were identified during manufacturing.Based on the available information we are not able to determine a definitive root cause at this time.

• Brand Name: PROTECTOR P50
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11389250
• Report Number: 3003152976-2021-00113
• Device Sequence Number: 4125990
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: 00382905151057
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 05/31/2025
• Device Catalogue Number: 515105
• Device Lot Number: 2006138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1