MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P55; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is a complaint about leakage occurred when preparing abraxane.According to the customer report two leaks occurred when preparing abraxane.In the first case, the rubber stopper collapsed when the protector was attached, causing a leak.In the second case, bubbles formed between the vial and the protector even though it was attached properly.It seemed like the vial was leaking from a gap.
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
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: two protectors attached to vials, were provided to our quality team for investigation.Through visual inspection of one of the samples, the stopper was observed to be inside the vial, verifying the reported incident.It was noted the protector punctured the vial off center, damaging the stopper cap, resulting in the stopper being pushed in as observed.Functional testing was performed on the other sample provided, in all cases the product functioned properly and no leakages were observed.A device history review was performed for reported lot 2312115, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples of the reported lot were used for additional evaluation.All protectors were assembled using the m12 assembly fixture.In all cases, liquid could successfully move to the vial and back to the syringe without issue and no leakage between the protector and vial was observed.Product undergoes visual and functional testing throughout manufacturing to ensure the quality and functionality of the device, including leakage testing.Testing results were reviewed for lot 2312115 and no issues were identified, product was verified to meet required specifications.Based on the investigation results and sample evaluation, it was determined that the protector was not properly connected to the vial which resulted in the leak reported.The protector must be attached completely vertical.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a slow and consistent motion.Complaints received for this device and reported condition will continue to be monitored by our quality team.

• Brand Name: PROTECTOR P55
• 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: 20291264
• Report Number: 3003152976-2024-00517
• Device Sequence Number: 20625762
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170(11)231220(17)281130(10)2312115
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• 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): 01/05/2025

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: 515117
• Device Lot Number: 2312115
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 01/05/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 01/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown