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
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
Foreign object found in paclitaxel bag.Event details: 11 vials of 30ml paclitaxel nk were used to prepare the drug, and after collecting the drug solution from each vial, it was injected into an infusion bag.When checked the inside of the bag before dispensing the infusion bag, a foreign object was found.(perhaps because some time has passed, there appears to be crystallized drug floating in the bag, separate from the coring.) the injector's lot is unknown.The incident occurred after the protector and injector were connected.The drug added was paclitaxel.Additional information: the product that was connected to the infusion bag was 515309.1: paclitaxel is a drug that is said to have the potential to crystallize (this is also written in the package insert), but the problem here is not that part, but the coring that is mixed in the infusion bag.It is mentioned to prevent the crystals from getting in the way and preventing the coring from being found.2: it's highly likely that it's the same injector.In that case, it may have made 22 round trips.515005 lot is unknown.3: the l connector is connected, and the collected drug is injected into the infusion bag from the l connector.
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 device 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.Based on visual characteristics 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.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.

• 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: 22327651
• Report Number: 3003152976-2025-00308
• Device Sequence Number: 18537514
• 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): 01/14/2026

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: 01/14/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 01/15/2026
• 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