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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN TRIPLE LUMEN CATHETER; CHRONIC CATHETERS

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BARD ACCESS SYSTEMS HICKMAN TRIPLE LUMEN CATHETER; CHRONIC CATHETERS Back to Search Results
Model Number 0606560
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It was reported that some time post implant of the chronic catheter during administration of medication, the white lumen allegedly cracked.It was further reported that the device was removed.There was no reported patient injury.
 
Event Description
It was reported that some time post implant of the chronic catheter during administration of medication, the white lumen allegedly cracked.It was further reported that the device was removed.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
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Brand Name
HICKMAN TRIPLE LUMEN CATHETER
Type of Device
CHRONIC CATHETERS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8204163
MDR Text Key131703711
Report Number3006260740-2018-03761
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741052019
UDI-Public(01)00801741052019
Combination Product (y/n)N
PMA/PMN Number
K830233
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number0606560
Device Catalogue Number0606560
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/04/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received02/28/2019
Supplement Dates FDA Received03/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
Patient Weight81
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