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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); BLOOD ACCESS AND ACCESSORIES
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BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); BLOOD ACCESS AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problems Fluid/Blood Leak (1250); Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2017
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reau2393 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
 
Event Description
It was reported by the doctor that there appeared to be a split of about one centimeter below the thumb clamp at the venous section of the catheter one hour after filling, placing, and locking the catheter normally.There was blood leakage after drawing blood again and extravasation occurred when saline and heparin was administered.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a slit in the venous extension leg was confirmed and it appeared that the catheter was damaged during use.One 19cm hemostar catheter was returned for investigation.The catheter was received in two segments.The d/l tubing had been cut between the 3 and 4 cm depth marks.The catheter exhibited evidence of use.What appeared to be dry blood residue was embedded in the cuff fibers.Impressions were observed in the extension legs from clamping.The extension legs were slightly yellowed.A 1.1cm slit was observed in the venous extension leg.A microscopic examination of the slit revealed striations in the adjoining surfaces of the catheter.Sharp edges were also observed along the length of the slit.The observed damage is consistent with sharp instrument damage.Due to the condition of the returned sample, it appeared that the catheter was damaged during use.A lot history review (lhr) of reau2393 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the doctor that there appeared to be a split of about one centimeter below the thumb clamp at the venous section of the catheter one hour after filling, placing, and locking the catheter normally.There was blood leakage after drawing blood again and extravasation occurred when saline and heparin was administered.There was no reported patient injury.
 
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Brand Name
HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM)
Type of Device
BLOOD ACCESS AND ACCESSORIES
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. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6932645
MDR Text Key89652627
Report Number3006260740-2017-01803
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741013386
UDI-Public(01)00801741013386
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K051748
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 01/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number5833690
Device Lot NumberREAU2393
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2017
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received12/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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