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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; DIALYSIS CATHETER

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BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATH; DIALYSIS CATHETER Back to Search Results
Catalog Number 6393230
Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2019
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.(expiration date: 04/2021).
 
Event Description
It was reported that sometime post dialysis catheter placement, the catheter was allegedly dislodged due to failed tissue in-growth on cuff.There was no reported patient injury.
 
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Brand Name
GLIDEPATHHEMODIALYSISCATH
Type of Device
DIALYSIS 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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key9418330
MDR Text Key169314259
Report Number3006260740-2019-03770
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741138508
UDI-Public(01)00801741138508
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K051748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6393230
Device Lot NumberREDS4918
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/08/2019
Initial Date FDA Received12/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2019
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 Age46 YR
Patient Weight76
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