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

Catalog Number	515117
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that human hair-like substance was found inside the protector.There is something that looks like human hair inside the balloon.(b)(6) addendum: anti-cancer drug via in protector.A foreign object was found while the cable was connected.Drug: cyramza.
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 protector was provided to our quality team for investigation.Through visual inspection, a hair is observed within the expansion chamber.A device history review was performed for the reported lot 2309115, 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.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

• 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: 19643086
• Report Number: 3003152976-2024-00389
• Device Sequence Number: 15605829
• 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): 12/13/2024

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: 515117
• Device Lot Number: 2309115
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown