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

Model Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that protector p53 leaked.The following information was provided by the initial reporter: "this is a report about leakage of chemo between the protector and the vial.The drug used is cisplatin.".
Additional Manufacturer Narrative
H6: investigation summary: one sample was returned to our quality engineer for investigation.The product was visually inspected, no issues were observed on the protector membrane.It was noted that the protector did not properly fit onto the vial, the protector clips are longer than the height of the vial neck, which can lead to a leak between the protector and vial.Initial testing identified liquid could not flow between the syringe and vial as the injector was not penetrating the vial stopper.The protector was reconnected using the m12 assembly fixture.Functional testing was performed and liquid inside the syringe could successfully move to the vial and back to the syringe without issue and no leakage was observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.A device history review was performed for lot 1604018, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.Based on our investigation it appears the leakage was a result of the protector not securely fitting onto the vial.The protector must be attached completely vertical when attaching onto the vial.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that protector p53 leaked.The following information was provided by the initial reporter: "this is a report about leakage of chemo between the protector and the vial.The drug used is cisplatin.".

• 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: 10506515
• Report Number: 3003152976-2020-00401
• Device Sequence Number: 3161321
• 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): 11/13/2020

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: Other
• Device Expiration Date: 03/31/2021
• Device Model Number: 515107
• Device Catalogue Number: 515107
• Device Lot Number: 1604018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 11/16/2020
• 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