MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P55; INTRAVASCULAR ADMINISTRATION SET

Model Number	515117
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 during use with bd phaseal¿ protector p55 the spike was discovered to be broken when attempting to attach to vial.This affected 13 devices.The following information was provided by the initial reporter, translated from japanese to english: this report is about phaseal protector p55.During the preparation of treakisym, the spike was found broken when attempting to attach the product (p55) to the vial.
Event or Problem Description
It was reported that during use with bd phaseal¿ protector p55 the spike was discovered to be broken when attempting to attach to vial.This affected 13 devices.The following information was provided by the initial reporter, translated from japanese to english: this report is about phaseal protector p55.During the preparation of treakisym, the spike was found broken when attempting to attach the product (p55) to the vial.
Additional Manufacturer Narrative
H6: investigation summary fourteen samples were provided to our quality team for investigation.Through visual inspection, the tip of the protector spikes are observed to be bent, verifying the reported incident.A device history review was performed for the reported lot 2204113, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Five retained samples of the same lot were used for additional evaluation.No damage to the protector spikes was observed.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.While we could not identify a direct issue, it was determined the damage likely occurred during the assembly process when the piece moved between machines.

• Brand Name: BD PHASEAL¿ PROTECTOR P55
• 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 ; 8448235433
• MDR Report Key: 17215953
• Report Number: 3003152976-2023-00256
• Device Sequence Number: 14206020
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• 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): 06/28/2023

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 Model Number: 515117
• Device Catalogue Number: 515117
• Device Lot Number: 2204113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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