MAUDE Adverse Event Report: CAREFUSION, INC BD¿ EPIDURAL TRAY SINGLE SHOT, DOUBLE DECK TUOHY 18 GAUGE 3-1/2 INCH

Catalog Number 406091

Device Problems Problem with Sterilization (1596); Packaging Problem (3007)

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

Event Date 09/07/2018

Event Type  malfunction  

Manufacturer Narrative

The pma/510(k)#: enforcement discretion.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 Description

It was reported that bd¿ epidural tray single shot, double deck tuohy 18 gauge 3-1/2 inch exhibited packaging failure and breach in sterility.No serious injury or medical intervention was reported.

Manufacturer Narrative

A sample was provided for evaluation.Evaluation of the sample confirmed the internal wrap was torn within the field of the wrap therefore failure mode is verified.The complaint sample evaluation was not able to identify a potential source for the tear.The probable root cause could not be identified.A review of the device history record shows that all inspection results passed per the dhr process and no anomalies were noticed during production.All anesthesia tray packaging are all 100% inspected throughout the process.Based on the evidence of the punctured wrap, which is highly visible, the defect would have triggered a rejection by the manufacturing personnel immediately.It is possible the tray caused the wrap to tear handling or during transportation post manufacturing.Consequently, the investigation was not able to identify a probable root cause.

Event Description

It was reported that bd epidural tray single shot, double deck tuohy 18 gauge 3-1/2 inch exhibited packaging failure and breach in sterility.No serious injury or medical intervention was reported.

• Brand Name: BD¿ EPIDURAL TRAY SINGLE SHOT, DOUBLE DECK TUOHY 18 GAUGE 3-1/2 INCH
• Type of Device: EPIDURAL TRAY
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7926339
• MDR Text Key: 122644394
• Report Number: 1625685-2018-00041
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904060916
• UDI-Public: 00382904060916
• 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: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 406091
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other