MAUDE Adverse Event Report: CAREFUSION, INC BD® WHITACRE SPINAL NEEDLE 27 G X 4 11/16 IN.; ANESTHESIA CONDUCTION KIT

Model Number	405828
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd® whitacre spinal needle 27 g x 4 11/16 in.The adaptor was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the catheter to be disconnected.
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.
Event or Problem Description
It was reported while using bd® whitacre spinal needle 27 g x 4 11/16 in.The adaptor was damaged.There was no report of patient impact.The following information was provided by the initial reporter: the catheter to be disconnected.
Additional Manufacturer Narrative
Investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD® WHITACRE SPINAL NEEDLE 27 G X 4 11/16 IN.
• 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 ; 8015296192
• MDR Report Key: 16248947
• Report Number: 1625685-2023-00008
• Device Sequence Number: 6453324
• 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): 02/09/2023

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: 01/05/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 02/27/2023
• 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