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

Model Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation: no photos or physicals samples that display the reported issue were provided for investigation.A device history was performed and found no no-conformances related to the reported issue during production of lots 1704010 and 1910111.Four retained samples of each lot were used for additional evaluation.Two samples of lot 1704010 and two of lot 1910111were connected to a standard 32mm vial using the m12 assembly fixture, in all instances the protectors properly fit the vial and no leakage was observed.The additional two samples of each lot where then connected to a vial of piperacillin/tazobactam using the m12 assembly fixture.In all samples it was noted that the protector was not to securely fit onto the vial and a leakage between the protector and vial was observed.Product is visually and functionally tested throughout the manufacturing process to ensure the quality and functionality of the device, including leakage testing.Test results were reviewed for the reported lots, all product met required specifications.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.It would appear the failure is related to the cap from the vial that was used which did not allow for a secure connection between the vial and protector.
Event or Problem Description
It was reported that the phaseal protector p53 is leaking.The following information was provided by the initial reporter: "phaseal protector is leaking when they using it on pip/taz with a thick vial.".

• Brand Name: PHASEAL 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: 9718045
• Report Number: 3003152976-2020-00062
• Device Sequence Number: 3068545
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/06/2020

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 Expiration Date: 04/29/2022
• Device Model Number: 515107
• Device Catalogue Number: 515107
• Device Lot Number: 1704010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/06/2020
• 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