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	04/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified number of bd phaseal¿ protectors (p55) from 12 cases of product had issues with broken/damaged spikes.The following information was provided by the initial reporter, translated from japanese: "the customer's\ report is as follows: broken air vent needles of p55 (lot#2204113) were found in 3 cases when the package was opened.Products with scratches like claw marks on the air vent needles were found in 9 cases.A total of 12 defects were observed and the hcp discontinued its use.".
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.
Additional Manufacturer Narrative
H6: investigation summary photos received by our quality team for investigation.Through visual inspection of the photos and reported device, the tip of the protector spike is observed to be damaged and missing, 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.
Event or Problem Description
It was reported that an unspecified number of bd phaseal¿ protectors (p55) from 12 cases of product had issues with broken/damaged spikes.The following information was provided by the initial reporter, translated from japanese: "the customer's verbatim report is as follows: broken air vent needles of p55 (lot#2204113) were found in 3 cases when the package was opened.Products with scratches like claw marks on the air vent needles were found in 9 cases.A total of 12 defects were observed and the hcp discontinued its use.".

• 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: 16883185
• Report Number: 3003152976-2023-00163
• Device Sequence Number: 7256710
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: Health Professional
• Device Model Number: 515117
• Device Catalogue Number: 515117
• Device Lot Number: 2204113
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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