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	05/16/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the bd phaseal¿ protector (p55) needles were bent and broken.The following information was translated from japanese to english: verbatim: the customer reported that plastic needles were bent and broken before use.
Event or Problem Description
It was reported that the bd phaseal¿ protector (p55) needles were bent and broken.The following information was translated from japanese to english: verbatim: the customer reported that plastic needles were bent and broken before use.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 22-may-2023.H.6.Investigation summary: sample and photos received by our quality team for investigation.Through visual inspection, the tip of the protector spike is observed to be damaged, broken, and missing the spike, verifying the reported incident.A device history review was performed for the reported lot 2204114, 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.The retained samples were inspected and 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.Manufacturing personnel have been notified of this incident to increase awareness.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Additional Manufacturer Narrative
H6: investigation summary photos received by our quality team for investigation.Upon visual evaluation, through visual inspection of the photos and reported device, the tip of the protector spike is observed to be damaged, verifying the reported incident.A device history review was performed for the reported lot 2204114, 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.The retained samples were inspected and 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.
Event or Problem Description
It was reported that the bd phaseal¿ protector (p55) needles were bent and broken.The following information was translated from japanese to english: verbatim: the customer reported that plastic needles were bent and broken before use.

• Brand Name: BD PHASEAL¿ PROTECTOR (P55)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• 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: 17095628
• Report Number: 3003152976-2023-00221
• Device Sequence Number: 16627237
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2023

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: 2204114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Supplement Date Received by Manufacturer: 06/30/2023; 08/21/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/20/2023; 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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