MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P14; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
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.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 experienced leakage.The following information was provided by the initial reporter: it was reported that the phaseal is leaking.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 experienced leakage.The following information was provided by the initial reporter: it was reported that the phaseal is leaking.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 15-oct-2022.H6: investigation summary: two unused samples of lot 2111120 were provided to our quality team for investigation.The product was visually inspected, no damage was observed on the cannula or in the area where it assembles into the protector housing that would indicate improper assembly.Functional tests were performed, connecting the protector to a vial using the m12 assembly fixture, as well as to a sample injector and a syringe.In all cases, the protector fitted correctly to the vial, the liquid could be withdrawn from the vial and the product functioned as intended.A device history review was performed for received lot 2111120, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Product undergoes visual and functional testing throughout manufacturing, according to procedure to ensure the quality and functionality of the device, no issues were found during production of lot 2111120.Based on our investigation and sample evaluation, we are unable to identify a root cause related to our manufacturing process at this time.

• Brand Name: BD PHASEAL¿ PROTECTOR P14
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15210639
• Report Number: 3003152976-2022-00365
• Device Sequence Number: 11279702
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/18/2022

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 Catalogue Number: 515100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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