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	11/27/2024
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
Verbatim: today i also had a leak with a vial of mvasi that was spiked yesterday.The liquid simply ran out through the ¿spike hole¿.Used the bottle of mvasi ( monoclonal anti body) the first time the day before with protector.Afterwards store it in the refrigerator and want to use it again the next day and then the liquid run out between the vial and the protector when did the incident occur? during use.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: one protector assembled with a vial, was provided to our quality team for investigation.Through visual inspection, a leak between the protector and vial was observed, verifying the reported incident.The protector was reassembled onto a vial used for testing which complies with the specification for the reported protector.Functional testing was performed, liquid was able to move from the syringe into the vial without issue and no leakage occurred.Upon further evaluation, the returned vial appeared slightly smaller than what is recommended for use with our protector.A device history review was performed for reported lot 2409405, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Three retained samples of the same lot were used for additional evaluation.The protectors were successfully connected to vials, ensuring they fit properly.The product was evaluated and no damage or defects were observed.Functional testing was performed and no leaks between the protector and vial was identified.Based on the investigation results, it appears the leak occurred due to the size of the vial, preventing a secure connection between the protector and vial.Complaints received for this device and reported condition will continue to be monitored by our quality team.
Event or Problem Description
No additional information.

• 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: 20844194
• Report Number: 3003152976-2024-00627
• Device Sequence Number: 8039451
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647(11)240930(17)260831(10)2409405
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/21/2025

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: 515064
• Device Lot Number: 2409405
• 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: 11/28/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 02/21/2025
• 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