MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 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	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr, if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Event details: this is a complaint about p50j protector coring during use.It was reported that endoxan and rituxan prepared.Assembly fixture used.Coaling fragments were observed in the vial.Rituxan collection vial was removed from p50 vial as the drug was collected.The coring fragments were collected while keeping a close eye on the vial, but the fragments moved and were difficult to find.2 rituxan vials are present.Note that a coma filter and capped needle are also enclosed.Lot number of the injector is 2501006.
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.No injector samples were returned.Three protectors, each connected to a vial, were provided to our quality team for investigation.During visual inspection, particles were observed within each vial.Characterization testing was performed and found the particles are consistent with material from the stopper of the vial.An additional particle within one of the vials was identified to be silicone, which would have originated from the syringe.It was also noted that the stoppers were significantly torn in the areas where the needle penetrated.No issues were found within the protector needle itself that could have contributed to this observation.A device history review was performed for injector lot 2501006.No deviations or nonconformances were identified during the manufacturing process that could have contributed to this observation.As the protector lot involved in this incident is unknown, a device history review cannot be performed.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.It is important to ensure the vial is not expired, as that can impact the quality of the rubber stopper.Based on our investigation and sample evaluation, it was determined that the stopper particles were generated during the assembly of the protector onto the vial.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

• Brand Name: PROTECTOR P50 MULTIPACK
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• 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: 23322179
• Report Number: 3003152976-2025-00568
• Device Sequence Number: 15937072
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2026

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: 09/25/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 04/28/2026
• 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