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	08/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
This is a complaint about onivide coring.Coring occurred during onivade preparation.2 vials were prepared.1 vial was returned to the infusion bag after visual inspection of the inside of the vial confirmed that no coring had occurred.The other vial (the one sent to us) had coring and we judged that it was not possible to collect.The company then checked the bag in which the first vial was returned and confirmed that coring had occurred.As a result, two vials were discarded.The injector and protector were connected.(the lot of injectors 515005 is 2410010).
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: it was reported that particles were observed inside the vial and iv bag during preparation.For investigation, one protector assembled onto a vial, one iv bag, one l-connector, and a spike set not manufactured by bd were provided to our quality team.Inspection of the returned samples confirmed the presence of a gray particle in both the vial and the infusion bag.Visual assessment determined that the particle in the vial originated from the vial stopper, while the particle found in the iv bag was consistent with material from the iv bag stopper.During evaluation, it was observed that the protector needle penetrated the vial stopper at a raised area, resulting in fragmentation of the stopper.A small stopper piece was also found within the protector needle.Additionally, the iv bag stopper was noted to be significantly torn.No damage or defects were identified within our devices 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.A device history review was performed for protector lot 2501110, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.As a lot number for the l-connector 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 investigation and sample evaluation, the vial stopper fragmentation was attributed to the protector needle piercing a raised portion of the stopper during assembly.Due to the extent of damage observed on the iv bag stopper, it was not possible to definitively determine which spike contributed to the observed particulate matter; therefore, a specific root cause could not be identified.No issues related to the injector were identified.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.
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 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22885199
• Report Number: 3003152976-2025-00469
• Device Sequence Number: 15651084
• 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): 03/22/2026

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: 2501110
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 03/22/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown