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	05/19/2025
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
It was reported that foreign object found in keytruda bag.Event details: two vials of keytruda were used to prepare the drug, and after collecting the drug solution from each vial, it was infused into an infusion bag, and before the infusion bag was dispensed to the nurse, the auditor checked inside the bag and found one small foreign object.We would like an analysis of the size of the coring.(it is mixed in the bag.) a lot of the injector is unknown.The event occurred after the protector and injector were connected.The product that was connected to the infusion bag was 515309.
Additional Manufacturer Narrative
Follow up mdr for device evaluation/correction: based on investigation results, this complaint is no longer reportable.The involved device did not contribute to the reported failure coring.It was reported that particles were observed inside an iv bag.For investigation, one iv bag, one l-connector, and a spike set not manufactured by bd were provided to our quality team.Upon inspection, a gray particle was observed inside the infusion bag, verifying the reported concern.Testing was performed and it was determined that the particle was consistent with material from the rubber stopper of the infusion bag.No damage or related defects were identified within our device that could have contributed to this observation.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.As a lot number was unavailable for this incident, a device history record review could not be completed.Coring of the rubber stopper may occur depending on stopper quality, design, or if a poor connection is made.Based on the available information, we cannot definitively identify which spike was responsible for the particle observed, therefore a root cause cannot be identified at this time.
Event or Problem Description
No additional information.

• 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: 22329105
• Report Number: 3003152976-2025-00317
• Device Sequence Number: 9582172
• 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): 01/16/2026

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: UNKNOWN
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown