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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 24CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED
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BARD ACCESS SYSTEMS NIAGARA DIALYSIS CATHETER KIT 13.5F X 24CM (SHORT-TERM) (DUAL-LUMEN); CATHETER, HEMODIALYSIS, NON-IMPLANTED Back to Search Results
Model Number N/A
Device Problems Break (1069); Positioning Failure (1158); Retraction Problem (1536); Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/28/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rect0894 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported normal appearance guide before use and during slipping before procedure.Difficulty descending the guide in the trocard then impossible withdrawal of the trocard guide.Withdrawal of the trocard.End of the guide bent and broken starting on trocard at the level of the loop.Use of another guide without complication.No other information was provided.
 
Event Description
It was reported normal appearance guide before use and during slipping before procedure.Difficulty descending the guide in the trocard then impossible withdrawal of the trocard guide.Withdrawal of the trocard.End of the guide bent and broken starting on trocard at the level of the loop.Use of another guide without complication.No other information was provided.
 
Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire was confirmed but the exact cause is unknown.One guidewire from a niagra dialysis catheter kit was returned for investigation.A kink near the j tip portion of the catheter was present.The coil near the kink location was slightly spread apart.The rest of the coil wire was intact with both weld tips present at the distal ends.A label sticker was also returned with lot: rect0894.The introducer needle was not returned.Microscopic observation revealed no apparent evidence of contact with the needle bevel.Manipulation of the proximal end of the guidewire revealed it to rigidly jerk.The proximal end of the guidewire was cut and the coil wire was unraveled to check the core wire integrity.No breaks in the proximal end of the core wires were observed.The kink at the distal end of the guidewire likely affected the mobility of the proximal end of the guidewire.Since a kink in the wire was observed and likely contributed to the reported event, the complaint is confirmed; however, the exact cause remains unknown.Possible contributing factors include retraction of the guidewire against the needle bevel and advancement against resistance.The product instructions for use (ifu) cautions, "caution: do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding.Withdraw needle and guidewire if cause of resistance cannot be determined." a lot history review (lhr) of rect0894 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
NIAGARA DIALYSIS CATHETER KIT 13.5F X 24CM (SHORT-TERM) (DUAL-LUMEN)
Type of Device
CATHETER, HEMODIALYSIS, NON-IMPLANTED
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8947123
MDR Text Key156261916
Report Number3006260740-2019-02537
Device Sequence Number1
Product Code MPB
UDI-Device Identifier00801741045585
UDI-Public(01)00801741045585
Combination Product (y/n)N
PMA/PMN Number
K030268
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number5593240
Device Lot NumberRECT0894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2019
Event Location Hospital
Date Manufacturer Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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