MAUDE Adverse Event Report: BECTON DICKINSON PROTECTOR P20-0; 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	02/12/2024
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.
Event or Problem Description
Material#:515064 batch#: unknown it was reported by customer that the customer was mixing doxorubicin and reported red drug leaking onto the membrane, protector itself and gloves.The customer was mixing doxorubicin and reported red drug leaking onto the membrane, protector itself and gloves.
Additional Manufacturer Narrative
Pr (b)(4)- follow up mdr for correction.Following the submission of the initial mdr, it was noted that the incorrect material number and description were provided.D4: updated with corrected material number and product description.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr #2 for correction.
Event or Problem Description
Material#:515064; batch#: unknown.Verbatim: the customer was mixing doxorubicin and reported red drug leaking onto the membrane, protector itself and gloves.
Additional Manufacturer Narrative
Sample and photo received for investigation.Through initial evaluation, the membranes are observed to have been punctured and a reddish color can be seen on the membrane.Functional testing was performed on the returned samples, after passing liquid through the system and disconnecting the injector from the protector, no liquid or evidence of a leak was observed.A device history review was performed for lot 2309405, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage and pressure testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for returned lot 2309405, and all results were found to be acceptable.The performance of the sealing membrane is reduced after multiple perforations and extended activation time, the membranes are designed to be punctured up to ten times.Based on the sample evaluation and quality team's investigation, we cannot identify a root cause at this time.
Event or Problem Description
No additional information.

• Brand Name: PROTECTOR P20-0
• 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: 18806308
• Report Number: 3003152976-2024-00107
• Device Sequence Number: 7295059
• Product Code: ONB
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 08/22/2024

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 515064
• Device Lot Number: 2309405
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 02/13/2024; 02/13/2024; 08/22/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 03/11/2024; 03/13/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown