MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P13-O; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	515060
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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 # unknown.Batch # unknown.It was reported by customer that they noticed a hair or fiber that was imbedded into device between the port and the white plastic surrounding it.Verbatim: the tech attached the protector to the vial but when she went to use it, she noticed a hair or fiber that was imbedded into device (between the port and the white plastic surrounding it).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr 10363035 follow up mdr for device evaluation: one photo was provided to our quality team for investigation.Upon visually inspecting the photo, a hair was observed on the membrane.A device history review was performed for the suspected lots 2306401, 2304402, 2207601, 2307403, and 2310402, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.All individuals are required to follow proper gowning procedures before entering the room, including hair protection.While we could not identify a direct issue, the root cause of this incident is due to personnel not following the proper gowning procedure.A project has been initiated to reduce any foreign material within our products.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: PROTECTOR P13-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: 19604230
• Report Number: 3003152976-2024-00367
• Device Sequence Number: 7326684
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2024

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: 515060
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 12/04/2024
• 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