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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 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged catheter dislodgement as no objective evidence has been provided to confirm any alleged deficiency with the cuff.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.(expiration date: 12/2020).
 
Event Description
It was reported that some time post dialysis catheter placement, the catheter allegedly became dislodged with exposure of the cuff.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged failed tissue ingrowth as no objective evidence has been provided to confirm any alleged deficiency with the cuff.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Expiration date: 12/2020.
 
Event Description
It was reported that some time post dialysis catheter placement, the cuff allegedly failed to adhere to the tissue which resulted in catheter dislodgement.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
MDR Report Key8932158
MDR Text Key155641162
Report Number3006260740-2019-02511
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741138508
UDI-Public(01)00801741138508
Combination Product (y/n)N
PMA/PMN Number
K051748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/08/2019
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 Number6393230
Device Lot NumberREDP3359
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/31/2019
Initial Date FDA Received08/26/2019
Supplement Dates Manufacturer Received09/13/2019
Supplement Dates FDA Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age51 YR
Patient Weight79
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