MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P13-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515060
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 515063, batch#: 2409415.Membrane of 515063 was shiny upon disconnect.Customer responded on 10-mar: 1.Please share the lot number associated with reported issue lot#: 2409415.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patent harm or injury was reported.3.Please confirm what medication was being used? was there visible liquid droplets on the membrane or it had a shiny appearance? vincristine.From what was reported, there was no visible liquid/droplet on the membrane.When disconnected, the membrane had a shiny appearance.
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.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one sample was provided to our quality team for investigation.Through visual inspection, no staining or evidence of lubricant was observed on the membrane.Functional testing was performed, penetrating the injector membrane, in all cases the product functioned as intended and no leakage was observed.After testing, a cloth was used to wipe across the membrane, no evidence of fluid or any leak was found.A device history review was performed for protector lot 2409415; 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 lot, and all results were found to be acceptable.Three retained samples from lot 2409415 were used for additional evaluation.The membranes were punctured up to ten times, in all cases the product functioned as intended and no leakages or evidence of contamination on the membrane 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 lot 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 P13-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: 21646284
• Report Number: 3003152976-2025-00091
• Device Sequence Number: 20721332
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609(11)240930(17)260831(10)2409415
• 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): 05/19/2025

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: 08/31/2026
• Device Catalogue Number: 515060
• Device Lot Number: 2409415
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown