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U.S. Department of Health and Human Services

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

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CAREFUSION, INC BD¿ EPIDURAL TRAY SINGLE SHOT, DOUBLE DECK TUOHY 18 GAUGE 3-1/2 INCH Back to Search Results
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.
 
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Brand NameBD¿ EPIDURAL TRAY SINGLE SHOT, DOUBLE DECK TUOHY 18 GAUGE 3-1/2 INCH
Type of DeviceEPIDURAL TRAY
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key7926339
MDR Text Key122644394
Report Number1625685-2018-00041
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
SEE H.10
Number of Events Reported1
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 Received10/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number406091
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/02/2018 Patient Sequence Number: 1
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