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	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.
Event or Problem Description
The following was opened in relation to (b)(6) based on additional products received.It was reported by rep: the account had noted that they were experiencing the residual drug on all three components: p-13, c-100, p-20.Since i have been in the account, they have not experienced this specific issue again.The products that were returned were unused but in the same lot as the ones that experienced these issues.No user or patient impact.Yes, my clinical specialist and i went in and provided additional education to the team and they feel confident with all components now.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one unused p13-o protector, was returned 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 lot 2407806, 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.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 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: 21860675
• Report Number: 3003152976-2025-00150
• Device Sequence Number: 20016658
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609(11)240730(17)260630(10)2407806
• 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: 06/30/2026
• Device Catalogue Number: 515060
• Device Lot Number: 2407806
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown