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

Catalog Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ protector p53 experienced leakage.The following information was provided by the initial reporter: leakage from phaseal protector p53 when using pip/tazo sandoz 4/05g.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: no samples or photos were received for investigation.A device history review was performed for lot 2105120, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples from the same lot were used for further evaluation.The protectors were successfully connected to the vials, ensuring that they fit correctly.The product was evaluated, and no damage or defects were observed.Functional tests were performed on the samples and no leakage was identified between the protector and the vial.The product undergoes visual and functional testing throughout manufacturing, including leak testing.Results were reviewed for lot 2105120 and found no problems related to the reported event.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.It is likely the protector was not properly attached, resulting in the leak reported.The protector must be attached completely vertical to the vial during assembly.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a slow and consistent motion.
Event or Problem Description
It was reported that the bd phaseal¿ protector p53experienced leakage.The following information was provided by the initial reporter: leakage from phaseal protector p53 when using pip/tazo sandoz 4/05g.

• Brand Name: BD 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
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17410812
• Report Number: 3003152976-2023-00301
• Device Sequence Number: 15624496
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 04/30/2026
• Device Catalogue Number: 515107
• Device Lot Number: 2105120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown