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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT,14.5 FR,ST,19CM, STAND KIT; DIALYSIS CATHETER

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BARD ACCESS SYSTEMS HEMOSPLIT,14.5 FR,ST,19CM, STAND KIT; DIALYSIS CATHETER Back to Search Results
Model Number 5733690
Device Problems Defective Component (2292); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2019
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.The photo review is pending.The investigation is currently underway.
 
Event Description
It was reported that approximately three months post dialysis catheter placement that the device allegedly dislodged.It was further reported that the device was removed and replaced.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review could not be performed as the lot number was not provided.Investigation summary: a sample evaluation could not be performed as the samples were not returned.However one electronic photo was received.The photo shows one dialysis catheter, with residual blood on it, wrapped within a cotton bandage with the distal end of the catheter up to slightly past the cuff protruding out of the wrapping bandage.The cuff is entirely covered in blood residue and from the photo it is not possible to judge presence of any tissue ingrowth.The investigation is inconclusive for defective/damaged cuff as there is not enough evidence to confirm a product deficiency.Although a definitive root cause could not be determined, no tissue in-growth in the cuff, cuff attachment surface area not sufficient, poor material selection, or excessive force onto the cuff or catheter could have potentially caused or contributed to the reported 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.
 
Event Description
It was reported that approximately three months post dialysis catheter placement, the catheter allegedly dislodged due to failed tissue in-growth.It was further reported that the device was removed and replaced.There was no reported patient injury.
 
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Brand Name
HEMOSPLIT,14.5 FR,ST,19CM, STAND KIT
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8817338
MDR Text Key151916412
Report Number3006260740-2019-02102
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741013096
UDI-Public(01)00801741013096
Combination Product (y/n)N
PMA/PMN Number
K030020
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 Model Number5733690
Device Catalogue Number5733690
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/26/2019
Initial Date FDA Received07/23/2019
Supplement Dates Manufacturer Received09/25/2019
Supplement Dates FDA Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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