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	08/21/2025
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
It is reported leakage.Event description: my team have noticed an issue with the optima.We have been seeing "leakage".We have noticed a coloured spot on the tip of the p20-o after we remove a dose.This more noticeable on the coloured chemotherapy (eg doxorubicin).
Additional Manufacturer Narrative
Additional information: following submission of initial mdr, material number was updated and additional details received.Section d updated to reflect correct material.See section b for additional details provided by the customer.
Event or Problem Description
Additional information: p20-o batch 2408404: i have attached 2 photos albeit not the best quality.It is also not an isolated occurrence.There is definite residue on the top of the p20-o.We know this as when we wipe it, we can see some red staining on the wipe.You can also see some red residue on the injector.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two photos were provided to our quality team for investigation.Through visual inspection, the protector membrane appears to have a red coloring.A device history review was performed for protector lot 2408404, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for reported lot 2408404 and all results were found to be acceptable.The performance of the sealing membrane is reduced after multiple perforations and extended activation time, the membranes are designed to be punctured up to ten times.Three retained samples 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 investigation, no root cause related to the manufacturing process could be identified at this time.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.

• 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: 22896784
• Report Number: 3003152976-2025-00473
• Device Sequence Number: 5986514
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647(11)240824(17)260731(10)2408404
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181221
• 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): 10/23/2025

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: 07/31/2026
• Device Catalogue Number: 515064
• Device Lot Number: 2408404
• 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: 08/25/2025; 10/21/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/04/2025; 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown