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	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Materials#: 515064 ,batch#: unknown.It was reported by the customer that the product is leaking after they attach the product together.Verbatim: rcc received a complaint via phone.Pir attached.The product is leaking after they attach the product together.515064, 515056, 515979.
Additional Manufacturer Narrative
(b)(4) follow up mdr for additional information/evaluation: per sales rep, we have been to this clinic and worked with them on proper use of phaseal optima.They were not using it correctly so it is not a product issue.Our team trained the staff on proper usage moving forward.
Event or Problem Description
Materials#: 515064, batch#: unknown.It was reported by the customer that the product is leaking after they attach the product together.Verbatim: rcc received a complaint via phone.Pir attached.The product is leaking after they attach the product together.515064, 515056, and 515079.Per follow up with rep: we have been to this clinic and worked with them on proper use of phaseal optima.They were not using it correctly so it is not a product issue.Our team trained the staff on proper usage moving forward.

• 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 IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18884753
• Report Number: 3003152976-2024-00152
• Device Sequence Number: 7605440
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2024

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: 515064
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown