MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P20-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515064
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
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.Two batch numbers provided batch: 2405403 batch creation date: 2024-05-17 batch expiration date: 2026-04-30 full udi: (b)(4).Batch: 2406413 batch creation date: 2024-06-25 batch expiration date: 2026-05-31 full udi: (b)(4).
Event or Problem Description
Material# 515064 batch# 2405403 and 2406413.P-20 protectors (515064) are leaking residue on the membrane consistently.Additional information: during the detachment of the bd optima injector (n40 and/or n-35) from the vial components (bd optima protector p-20 or bd optima infusion adapter c100-o), we consistently notice visible drug residue left on the top of the vial adapter.There has been no patient harm or injury.We are just concerned for our team members who are being exposed to hazardous drug residue during preparation of these medications.It appears that liquid is coming out of the membrane.This is also occurring after the first withdrawal.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: one unused p20-o optima protector from lot 2405403 was provided to our quality team for investigation.Functional testing was performed; liquid was passed through the system and no evidence of any leak was identified.Upon disengaging the injector from the mating component, a cloth was used to wipe across the membranes, no evidence of fluid or any leak was found.A device history review was performed for protector lots 2406413 and 2405403, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for all provided lots, and all results were found to be acceptable.Three retained samples from p20-o protector lots 2405403 and 2406413 were used for additional evaluation.The membranes were punctured up to ten times, in all cases the product functioned as intended and no leakages occurred.Based on the sample evaluation and quality team's investigation, we cannot identify a root cause related to our process at this time.To date, there have been no other similar events reported for the lots provided.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: PROTECTOR P20-O
• 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: 21196863
• Report Number: 3003152976-2025-00014
• Device Sequence Number: 7577982
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 515064
• Device Lot Number: SEE H TAB-MULTIPLE LOT #S
• 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: 01/09/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 05/01/2025
• 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