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	Break (1069)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	05/28/2025
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
Verbatim: material # 515064, batch # 2502707.We had a cstd malfunction last night.The protector spike came out of the device when the technician tried attaching it to the vial.Additional information: 1.Could you please confirm if you attach the protector manually or using the assembly fixture? what medication was being used during this incident? we attach manually.The drug was valproic acid.2.Did leak occurred? no.3.Was there any harm to the patient/caregiver? (detail) no harm.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation one protector sample was provided to our quality team for investigation.Through visual inspection, the protector spike is broken, verifying the reported incident.A device history review was performed for reported lot 2502707, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this observation.Retained samples of the reported lot were used for additional evaluation.The product was thoroughly inspected and no damage or defects were observed.Functional testing was performed; in all cases the protectors were properly fitted to the vial without issue and no damage to the spike occurred.Product is visually and functionally tested throughout manufacturing according to procedure, ensuring the quality and functionality of the device, including verification that all critical dimensions are within specification, no issues related to the reported issue were noted.Based on our investigation we cannot identify a root cause related to our manufacturing process at this time.To date, there have been no other similar events reported for this lot.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.

• 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: 22183144
• Report Number: 3003152976-2025-00271
• Device Sequence Number: 18342733
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647(11)250227(17)270131(10)2502707
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/11/2025

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: 515064
• Device Lot Number: 2502707
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown