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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH HEMODIALYSIS CATHETER; LONG-TERM HEMODIALYSIS CATHETER

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BARD ACCESS SYSTEMS GLIDEPATH HEMODIALYSIS CATHETER; LONG-TERM HEMODIALYSIS CATHETER Back to Search Results
Catalog Number 6393190
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will 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.(expiry date: 10/2019).
 
Event Description
It was reported that approximately two months post catheter insertion, the catheter allegedly dislodged.Reportedly, the device was removed and replaced.There was no reported patient injury.
 
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Brand Name
GLIDEPATH HEMODIALYSIS CATHETER
Type of Device
LONG-TERM HEMODIALYSIS CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX   88780
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key8742131
MDR Text Key149641028
Report Number3006260740-2019-01794
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741138492
UDI-Public(01)00801741138492
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K051748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/27/2019
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 Catalogue Number6393190
Device Lot NumberRECQ0718
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/04/2019
Initial Date FDA Received06/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age63 YR
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