MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS 13.5FX15CM DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	5593150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a stuck guidewire is confirmed.One 70 cm guidewire and one introducer needle were returned for evaluation.The guidewire was returned extending 18 cm from the distal end of the introducer needle.An attempt to advance the guidewire was unsuccessful due to resistance experienced.Additional force was required to remove the guidewire was the distal end of the needle.Residue from use, which included what appeared to be tissue residue, was visible on the guidewire.The outer diameter of the guidewire was measured and was found to be within manufacturing specification.The guidewire coils were observed to be elongated and slightly kinked near the stuck region.Microscopic observation of the needle bevel revealed deformation consistent with damage caused by retraction of the guidewire against the needle bevel.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 redx1345 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in (b)(6).
Event or Problem Description
It was reported that the guide wire could not be removed anymore from the cannula (puncture needle).No other information was provided.It was reported this event occurred twice.This report addresses the first event.

• Brand Name: NIAGARA DIALYSIS 13.5FX15CM DL
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11061886
• Report Number: 3006260740-2020-21049
• Device Sequence Number: 14254887
• Product Code: MPB
• UDI-Device Identifier: 00801741045561
• UDI-Public: (01)00801741045561
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5593150
• Device Catalogue Number: 5593150
• Device Lot Number: REDX1345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other