MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P50 MULTIPACK; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515106
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coring was discovered during pepcid preparation.The injector and protector had already been connected.Collection was interrupted and another vial was used.Judging from the color, it appears to be abrasion of the membrane.(lot number for injector 515005 is 2410010.).
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: it was reported that particles were observed inside the vial during preparation.For investigation, one protector assembled onto a vial was provided to our quality team.Inspection of the returned sample confirmed the presence of a black particle inside the vial, as well as white foreign matter on the vial's rubber stopper and within the vial.No damage or defects were identified in the protector, membrane, or needle that would have contributed to these observations.During evaluation, it was noted that the protector's metal cannula penetrated a raised portion of the vial stopper rather than the intended flat puncture surface, resulting in tearing of the stopper.Microscopic examination confirmed that the black particle was consistent with material originating from the vial stopper.The white material observed could not be properly extracted; therefore, characterization testing could not be performed, and its origin could not be determined.Products from this manufacturing line are routinely sampled and subjected to visual and functional inspections throughout multiple manufacturing sub-processes in accordance with established procedures.A device history record review was conducted for protector lot 2501110 and injector lot 2410010, and no deviations or nonconformances were identified that could have contributed to this event.While phaseal needles are designed to reduce coring, coring may still occur due to several factors, including multiple punctures, excessive membrane welding, stopper quality, needle design and dimensions, or improper connection during use.Based on the investigation and sample evaluation, the vial stopper fragmentation was attributed to the protector needle piercing a raised portion of the stopper during assembly.Complaints related to this device and reported condition will continue to be tracked and trended, with routine review by the quality team to identify any emerging trends.

• Brand Name: PROTECTOR P50 MULTIPACK
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22885176
• Report Number: 3003152976-2025-00467
• Device Sequence Number: 8790370
• Product Code: ONB
• UDI-Device Identifier: 00382905151064
• UDI-Public: (01)00382905151064
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2026

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: 515106
• Device Lot Number: 2501110
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown