MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P14; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
The following was reported: we have a leaking issue with our p14 vial adaptors with the lot number #2404123.We have 36 unused adaptors remaining in the box.We were told by our distributor that y'all prefer to handle these issues directly with us rather than them.I called last week but i haven't heard back yet.If someone can call so that we can discuss the issue and what to do moving forward, that would be great.Per follow up from customer 14mar2025: 1.Can you please provide an exact date of event in format dd-mmm-yyyy? 21 feb 2025 (2 adaptors); 25 feb 2025 (1 adaptor); 26 feb 2025 (3 adaptors); 28 feb 2025 (1 adaptor); lot # 2404123.Additional information: yes, the leak is between the adapter and the vial.It was attached using the assembly fixture.No one was harmed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 2404123, 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 2404123, all results were found to be within specification.Retained samples of the same lot were used for additional evaluation.Functional testing was performed, connecting the protectors to 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 the available information, we cannot establish a root cause related to the manufacturing process, therefore a definitive root cause cannot be identified at this time.It is important the m12 fixture is used in a slow and consistent motion when attaching the protector onto the vial.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: PROTECTOR P14
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21728713
• Report Number: 3003152976-2025-00112
• Device Sequence Number: 18299176
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002(11)240412(17)290331(10)2404123
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: Health Professional
• Device Catalogue Number: 515100
• Device Lot Number: 2404123
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 03/30/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown