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

Catalog Number	515065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
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
Material # 515065.Batch # 2407417.Verbatim: when adding air to the vial while compounding, the injector (non-locking) and syringe popped off (still lured together) and caused chemo to shoot out of the top of the membrane on the vial protector.She clarified that the syringe and injector never separated, but that the leak was made after totally disengaging the membranes between the injector and the vial protector.The lot number for the protector involved in the incident is: 2407417 products#: 515064.Additional information received on 02dec.Yes, 515065 would be correct.There was no patient involved in this situation.No serious injury occurred but there was exposure to hazardous drug/chemo spill.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2407417, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, no issues were identified related to the reported event.Retained samples of the same lot were used for additional evaluation.Functional testing was performed, penetrating the protector membrane, all results were found to be acceptable with no leaks identified.Based on the available information we are not able to identify a root cause related to the manufacturing process 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.
Event or Problem Description
Material # 515065 batch # 2407417.When adding air to the vial while compounding, the injector (non-locking) and syringe popped off (still luered together) and caused chemo to shoot out of the top of the membrane on the vial protector.She clarified that the syringe and injector never separated, but that the leak was made after totally disengaging the membranes between the injector and the vial protector.The lot number for the protector involved in the incident is: 2407417 products#: 515064.Additional information received on 02dec.Yes, 515065 would be correct.There was no patient involved in this situation.No serious injury occurred but there was exposure to hazardous drug/chemo spill.Did they aspirate the amount of air equal to the volume needed, and inject the air into the vial before attempting to withdraw medication? customer response: i believe it was a fluke.I was pushing air into the vial and the syringe slipped off.I don¿t believe i had it completely on.I believe it to be user area.

• Brand Name: PROTECTOR P20-O MULTIPACK
• 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: 20854816
• Report Number: 3003152976-2024-00631
• Device Sequence Number: 18290701
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: (01)00382905150654(11)240731(17)260630(10)2407417
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 515065
• Device Lot Number: 2407417
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown