MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P53; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the protector p53 has been found experiencing two occurrences of leakage during use.The following has been provided by the initial reporter: when drawing cisplatin, drug leaked from between the protector and the vial.After leakage, customer pressed p53 to the vials and drew drug successfully.
Additional Manufacturer Narrative
Investigation: two samples were returned to our quality team for investigation.The product was visually inspected, no damage was observed and both samples were properly fitted to the vial.Samples were tested functionally, connecting to an injector and syringe.Liquid could move from the syringe into the vial and back to the syringe without issue and no leaks were observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.As lot information for this incident was not available, a device history review could not be performed.Based on the investigation results, it was determined that the protector was not properly connected to the vial which resulted in the leak reported.The protector must be attached completely vertical.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.
Event or Problem Description
It has been reported that the protector p53 has been found experiencing two occurrences of leakage during use.The following has been provided by the initial reporter: when drawing cisplatin, drug leaked from between the protector and the vial.After leakage, customer pressed p53 to the vials and drew drug successfully.

• Brand Name: PROTECTOR P53
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9262532
• Report Number: 3003152976-2019-00750
• Device Sequence Number: 18981401
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 515107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other