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	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This is a complaint about liquid leakage during use.It was reported that liquid leaked from a vial with a protector attached to it.It is unclear whether the leakage is from the protector or the vial.
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.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one sample was returned to our quality team for investigation.The product was inspected, no damage was observed on the protector and the protector spike was verified to have punctured the vial stopper properly.Functional testing was performed and no leakage between the protector and vial was observed.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including leakage testing and verification all critical dimension are within specification.As the lot involved in this incident is unknown, a device history review cannot be performed, and additional retained samples cannot be evaluated.It was identified during our evaluations that there was a film around the vial.It is possible this impacted the connection of the protector onto the vial.Given we did not observe any leakage during our testing, we cannot verify this to be true for the reported incident, therefore a definitive root cause cannot be established at this time.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 tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
This is a complaint about liquid leakage during use.It was reported that liquid leaked from a vial with a protector attached to it.It is unclear whether the leakage is from the protector or the vial.

• 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: 20611554
• Report Number: 3003152976-2024-00578
• Device Sequence Number: 20685646
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• 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): 01/30/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown