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	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
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
Verbatim: this is a complaint about coring.It was reported that after preparing nine doses of paclitaxel, core was observed when the drug was returned to the bag.The core was small, suggesting that it originated from the injector.Additional information could you please confirm whether coring occurred after the injector installed? if yes, could you please confirm the product code and lot number of the injector? after installing the injector, customer connected it to the protector and confirmed the occurrence when attempting to collect the liquid.The lot of the injector is unknown.Injector's product code is 515005.
Event or Problem Description
Additional information: provided lot# 2402101 is not valid for 515111? as per the sap system the lot# is refers to 515106.Could you please confirm which one is impacted material number.It was confirmed that protector's material number is (b)(4).
Additional Manufacturer Narrative
Follow up for additional information.See b tab and d tab.Device evaluation: no photographic evidence or physical samples were submitted to examine the reported condition.A comprehensive review of the device's history was performed for the optima protector p50j lot 2402101, revealing no deviations or non-conformances during the manufacturing process that could have led to the issue.Four retained samples were requested, and fragmentation tests were conducted, with results falling within specifications.During the fragmentation test, it was observed that none of the samples exhibited leakage between the protector and the vial, and the defect reported by the customer could not be replicated.This leads to the conclusion that our needles are not the cause of the perforation identified by the customer; rather, it is likely due to improper assembly or that the rubber stopper of the vial was in poor condition.The product is subjected to inspections at various stages of the manufacturing process to guarantee its quality and functionality.Given the information at hand, we are currently unable to pinpoint a root cause associated with the manufacturing process.Our quality team will persist in monitoring complaints related to this device and the reported condition for any potential emerging trends.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Follow up mdr for correction annex b, c, d updated.

• 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: 22069894
• Report Number: 3003152976-2025-00229
• Device Sequence Number: 12861484
• Product Code: ONB
• UDI-Device Identifier: 00382905151064
• UDI-Public: (01)00382905151064(17)290131(10)2402101
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201099
• 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,Followup
• Report Date (Section B): 07/15/2025

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: 2402101
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/14/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/07/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown