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

Catalog Number 405823

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2018

Event Type  malfunction  

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 Description

It was reported with the use of the bd¿ combined spinal & epidural trays there was an issue with needle length incorrect.

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 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
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8129848
• MDR Text Key: 129331382
• Report Number: 1625685-2018-00058
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058234
• UDI-Public: 00382904058234
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405823
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other