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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E; ANESTHESIA CONDUCTION KIT

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CAREFUSION, INC TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 406047
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Patient Involvement (2645)
Event Date 08/26/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that 2 trays epid cont we18g3.5 c20 lor5 s/l/l-e were found before use with 19g epidural catheters, rather than the 20g catheters indicated on the labeling.The following information was provided by the initial reporter: "our anesthesia group is coming across a component discrepancy.Bd continuous epidural tray 406047 is labeled as having a 20g x36 in epidural catheter.We have two trays that came with 19g.".
 
Event Description
It was reported that 2 trays epid cont we18g3.5 c20 lor5 s/l/l-e were found before use with 19g epidural catheters, rather than the 20g catheters indicated on the labeling.The following information was provided by the initial reporter: "our anesthesia group is coming across a component discrepancy.Bd continuous epidural tray 406047 is labeled as having a 20g x36 in epidural catheter.We have two trays that came with 19g.".
 
Manufacturer Narrative
Investigation summary: sample analysis confirmed the failure mode (incorrect component).Five (5) of the seven (7) samples returned contained the incorrect 19 gauge epidural catheter (blue label).Two (2) of the seven (7) samples contained the correct 20 gauge epidural catheter (white label).A review of the device history records identified no issues for lot 0001285103.The investigation noted that packaging of the (b)(4) is a manual process.As part of this manufacturing process, all components are to be verified with the applicable bill of material at start up and at any time during the manufacturing process when more components are delivered to the manufacturing line.Based on the dhr review results and the sample evaluation, the investigation identified the most probable root cause to be a failure in the component verification step with the applicable bill of materials during the manufacture of the affected finished good lot.Conclusion: based on the complaint investigation, the most probable root cause was that manufacturing personnel did not properly verify components as they were delivered to the manufacturing line.Based on the identified probable root cause, all applicable manufacturing associates have received awareness training regarding this particular incident.
 
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Brand Name
TRAY EPID CONT WE18G3.5 C20 LOR5 S/L/L-E
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
MDR Report Key8981156
MDR Text Key195565995
Report Number1625685-2019-00107
Device Sequence Number1
Product Code CAZ
UDI-Device Identifier00382904060473
UDI-Public00382904060473
Combination Product (y/n)N
PMA/PMN Number
DISCRETION
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/16/2019
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
Device Operator Health Professional
Device Expiration Date09/30/2020
Device Catalogue Number406047
Device Lot Number0001285103
Initial Date Manufacturer Received 08/26/2019
Initial Date FDA Received09/10/2019
Supplement Dates Manufacturer Received08/26/2019
Supplement Dates FDA Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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