MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P14; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Verbatim: same issue happened on second time which is on (b)(6) 2025 - the product is the phaseal protector p14.Ref number 515100.Lot no 2406113.- i'm writing to follow up on our previous investigation into leaking mitoxantrone bottles when used with the phaseal system.We did not initially keep the bottle phaseal set to send you for examination, however we have since used this drug again and had the same issue meaning this is the third time, but this time we retained the bottle.
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: same issue happened on second time which is on 20may2025 - the product is the phaseal protector p14.Ref number 515100.Lot no 2406113.I'm writing to follow up on our previous investigation into leaking mitoxantrone bottles when used with the phaseal system.We did not initially keep the bottle phaseal set to send you for examination, however we have since used this drug again and had the same issue meaning this is the third time, but this time we retained the bottle.Per customer response: we assemble manually.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one sample was returned to our quality team for investigation.Upon evaluation, we observed leakage between the vial and the protector, verifying the reported concern.Further inspection revealed that the needle on the protector had penetrated the vial off-center, damaging the metal cap around the stopper, which led to the leakage observed.A device history review was performed for reported lot 2406113, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.The product undergoes thorough visual and functional inspections throughout the manufacturing process to ensure both quality and performance.This includes leakage testing and verification that all critical dimensions meet specification requirements.Following a comprehensive review, no issues were identified during manufacturing that could be linked to the reported incident.Based on the investigation, it was determined that the protector was not properly aligned during attachment to the vial.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a slow and consistent motion.Complaints received for this device and reported condition will continue to be monitored by our quality team.

• Brand Name: PROTECTOR P14
• 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: 22158551
• Report Number: 3003152976-2025-00264
• Device Sequence Number: 7484182
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002(11)240610(17)290531(10)2406113
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/29/2025

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: 515100
• Device Lot Number: 2406113
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown