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	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported foreign object was found.Event details: 30ml of paclitaxel nk was prepared using 4 vials, and after collecting the liquid from each vial, it was injected into an infusion bag.When the auditor checked the inside of the bag before dispensing the infusion bag to the nurse, a foreign object was found.We would like you to analyze the size of the coring.(contaminated inside the bag) the lot of the injector is unknown.The incident occurred after the protector and injector were connected.The number of connections was about 9 times.4 vials and 1 infusion bag will be returned.Additional information: 1: this is the same injector.515005 lot is unknown.2: the l connector is connected, and the collected medication is injected from the l connector into the infusion bag.
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
No additional information.
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.One vial was also returned and no particles or other foreign matter was identified within the vial.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.

• 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: 22328029
• Report Number: 3003152976-2025-00311
• Device Sequence Number: 8430251
• 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