MAUDE Adverse Event Report: CAREFUSION, INC BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY; ANESTHESIA CONDUCTION KIT

Model Number	405828
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd bd® whitacre spinal needle and bd¿ weiss epidural needle tray the catheter adaptor dislodged.There was no report of patient impact.The following information was provided by the initial reporter: nexus catheter adapter came dislodged from catheter resulting in delay in medication adminstration.
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
One photo sample was received by our quality team for investigation.Upon visual inspection of the photo, we are unable to confirm how the product disconnected and the time of disconnect during the procedure.A device history record could not be evaluated as the lot number is unknown.H3 other text : see h10.
Event or Problem Description
It was reported while using bd bd® whitacre spinal needle and bd¿ weiss epidural needle tray the catheter adaptor dislodged.There was no report of patient impact.The following information was provided by the initial reporter: nexus catheter adapter came dislodged from catheter resulting in delay in medication adminstration.

• Brand Name: BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16441163
• Report Number: 1625685-2023-00028
• Device Sequence Number: 16927879
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: (01)00382904058289
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 04/25/2023

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: 405828
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 02/26/2023
• Supplement Report FDA Received Date: 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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