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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); CATHETER, HEMODIALYSIS, IMPLANTED

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BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (19CM); CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Model Number 5833690
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
 
Event Description
It was reported the catheter extension tube disconnected.There was no reported patient injury.
 
Manufacturer Narrative
H10: 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.Investigation summary: one d/l hemostar catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for extension leg separation from bifurcation, as the blue hub extension leg was separated from the bifurcation and break surfaces were observed on the distal end of the extension end and the proximal end of the bifurcation on the main catheter.The break surfaces appeared smooth and had striations mostly aligned towards the center of the lumen.Some damage was observed near the inner edge on the extension leg break surface.The definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.Excessive and/or repeated stresses and/or torques may have contributed to the reported extension leg separation from the bifurcation.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.H10: d4 (expiration date: 07/2019), d10, g4, h6 (device codes).H11: h3, h6 (method, results, conclusions).H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported the catheter extension tube disconnected.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
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7719616
MDR Text Key115011928
Report Number3006260740-2018-01825
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00801741013386
UDI-Public(01)00801741013386
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 04/03/2019
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 Number5833690
Device Catalogue Number5833690
Device Lot NumberREBV1809
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Initial Date Manufacturer Received 07/02/2018
Initial Date FDA Received07/25/2018
Supplement Dates Manufacturer Received03/27/2019
Supplement Dates FDA Received04/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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