MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515057
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n40-o multi) cracked at the threads.The following information was provided by the initial reporter: "phaseal optima injector cracked at the threads.Not sure if this cracked when pharmacy placed on the line, or when it was looked at by nursing.No known exposure or patient impact with this incident, but had potential to other comments unsure if this is possible due to over tightening or what could cause a crack in the threads.".
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 two photos were provided to our quality team for investigation.Through visual inspection, the thread is observed to be cracked, verifying the reported incident.A device history review was performed for lot 2305310, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Product undergoes a series of visual and functional evaluations throughout the manufacturing process, including verification the product is free from damage and all critical dimensions are within required specification.Records were reviewed for the reported lot and no issues related to this failure were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ optima injector (n40-o multi) cracked at the threads.The following information was provided by the initial reporter: "phaseal optima injector cracked at the threads.Not sure if this cracked when pharmacy placed on the line, or when it was looked at by nursing.No known exposure or patient impact with this incident, but had potential to other comments unsure if this is possible due to over tightening or what could cause a crack in the threads.".

• Brand Name: BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI)
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17836451
• Report Number: 3003152976-2023-00425
• Device Sequence Number: 7456579
• Product Code: ONB
• UDI-Device Identifier: 00382905150579
• UDI-Public: 00382905150579
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K201099
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 515057
• Device Lot Number: 2305310
• 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: 09/13/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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