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

Model Number	515100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ protector (p14) needle bends during and after piercing causing leakage.The following information was provided by the initial reporter: verbatim: the needle of the protector bends during/after piercing the septum: leaking.
Additional Manufacturer Narrative
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
The following fields were updated due to additional information: d10: device available for evalution?yes,.D10: returned to manufacturer on: 26-jun-2023 h6: investigation summary three protectors assembled onto a vial were provided to our quality team for investigation.Through visual inspection it was observed the protectors were not properly assembled onto the vial, the needles was noted to be crooked and pierced the vial off center.A device history review was performed for lot 2301128, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, no issues were found during testing.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 and must be used in a slow and consistent motion.
Event or Problem Description
It was reported that the bd phaseal¿ protector (p14) needle bends during and after piercing causing leakage.The following information was provided by the initial reporter: verbatim: the needle of the protector bends during/after piercing the septum --leaking.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17200131
• Report Number: 3003152976-2023-00247
• Device Sequence Number: 12204412
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: Health Professional
• Device Model Number: 515100
• Device Catalogue Number: 515100
• Device Lot Number: 2301128
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2023
• 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