MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P21; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515102
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It is reported foreign matter.Event description: while preparing several formulations over the past few days, we repeatedly found small black rubber particles in our vials.The only common factor between the different preparations was the use of protector p21 with lot number 2501102.When did the incident occur? - during use.
Event or Problem Description
It is reported foreign matter.Event description: while preparing several formulations over the past few days, we repeatedly found small black rubber particles in our vials.The only common factor between the different preparations was the use of protector p21 with lot number 2501102.When did the incident occur? - during use.Per additional customer response: is the protector assembled manually or using the assembly fixture? using the assembly fixture.Are the particles observed after assembling the protector? it was observed after assembling and before drawing fluid into the syringe.What medication is this occurring with? remsima, entyvio and abevmy.What color is the vial stopper? they are all grey.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: four protectors assembled with vials were provided to our quality team for review.After a thorough visual inspection, no damage, defects, or signs of contamination were found on the protectors, membranes, or any related components.We also attempted to filter the solution, and no particles were detected in the filter, the solution, or inside the vial.A device history review was completed for the reported lot 2504108.No deviations or non-conformances were identified during manufacturing that could have contributed to the concern.Products from this manufacturing line are sampled and undergo multiple visual and functional checks throughout the process, and no issues were noted during these inspections.Based on the sample evaluation and the results of our investigation, we were unable to verify the reported issue, and a root cause related to our device or manufacturing process cannot be established at this time.While phaseal needles are designed to reduce coring (fragmentation), there are several factors that may impact coring tendency including the quality of the vial stopper, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: PROTECTOR P21
• 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: 22850852
• Report Number: 3003152976-2025-00458
• Device Sequence Number: 4419504
• Product Code: ONB
• UDI-Device Identifier: 00382905151026
• UDI-Public: (01)00382905151026(11)250429(17)300331(10)2504108
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/11/2026

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: 515102
• Device Lot Number: 2504108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown