MAUDE Adverse Event Report: CAREFUSION, INC BD¿ COMBINED SPINAL & EPIDURAL TRAYS; ANESTHESIA CONDUCTION KIT

Catalog Number	405823
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Pma / 510(k) #: enforcement discretion.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported with the use of the bd¿ combined spinal & epidural trays there was an issue with needle length incorrect.
Additional Manufacturer Narrative
Correction: describe event or problem: it was reported with the use of the bd¿ combined spinal & epidural trays there was an issue with needle length incorrect.This issue was reported to have affected 5 devices.Investigation summary: a photo was received for evaluation.The photograph did not include any means to properly evaluate the length of the needle (no scaling), therefore the investigation could not confirm or deny the reported failure mode from the photograph submitted.Without a lot number, sample or conclusive photograph this investigation was unable to confirm the reported failure mode.Likewise, the investigation was not able to identify any contribution from manufacturing factors.As the failure mode was unable to be confirmed a corrective and/or preventive action could not be identified for this complaint.
Event or Problem Description
It was reported with the use of the bd¿ combined spinal & epidural trays there was an issue with needle length incorrect.This issue was reported to have affected 5 devices.

• Brand Name: BD¿ COMBINED SPINAL & EPIDURAL TRAYS
• Common Device Name: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8129848
• Report Number: 1625685-2018-00058
• Device Sequence Number: 11167084
• Product Code: CAZ
• UDI-Device Identifier: 00382904058234
• UDI-Public: 00382904058234
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (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): 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 405823
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other