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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS GLIDEPATHHEMODIALYSISCATHETER; 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 07/01/2019
Event Type  malfunction  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and 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: a sample evaluation could not be performed as the samples were not returned.However, two (2) electronic photos were reviewed.The first photo shows the catheter partially in the patient and the cuff can be seen having came out of the patient.The second photo shows a slightly different view of the catheter with the cuff having come out of the patient, the lumens in this photo seem clearer than in the first picture where the lumens seemed more opaque.From the photo it is clear the catheter has dislodged and that the cuff is no longer connected to the tissue in the patient.The investigation is confirmed for catheter dislodgement.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported 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.
 
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.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and 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: a sample evaluation could not be performed as the samples were not returned.However, two (2) electronic photos were reviewed.The first photo shows the catheter partially in the patient and the cuff can be seen having came out of the patient.The second photo shows a slightly different view of the catheter with the cuff having come out of the patient, the lumens in this photo seem clearer than in the first picture where the lumens seemed more opaque.From the photo it is clear the catheter has dislodged and that the cuff is no longer connected to the tissue in the patient.The investigation is confirmed for a damaged/defective cuff.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Expiration date: 12/2020.
 
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Brand Name
GLIDEPATHHEMODIALYSISCATHETER
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8932048
MDR Text Key155574500
Report Number3006260740-2019-02508
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 09/17/2019
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 Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age15 YR
Patient Weight35
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