MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
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 guidewire stuck in an introducer needle was confirmed.The products returned for evaluation were one 0.038 in.J-tip guidewire and one 18 g introducer needle.The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle.An initial visual observation showed use residue on the returned samples.The guidewire was found to be stuck within the returned introducer needle, and the j-tip of the guidewire was observed protruding from the distal end of the needle.The core wire of the guidewire was observed to be broken.A microscopic observation revealed the bevel of the introducer needle was slightly damaged, which suggests the guidewire was retracted against the bevel.Once the guidewire was forcibly removed from the introducer needle, a large amount of biological residue was observed on the portion of the guidewire that was within the needle cannula.The break site of the core wire was observed to be tapered with a granular surface texture, which indicated a tensile failure.Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire.If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.The product ifu states: ¿do not pull back guidewire over needle bevel as this may sever the end of the guidewire.The introducer needle must be removed first.¿ a lot history review (lhr) of reex2165 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the puncture needle was in patient and guidewire was introduced.Then the patient had to be moved slightly in another position.Then guidewire was stuck in place and removal was only possible with removal of puncture needle.Even outside the body the needle and the catheter could not be separated.On (b)(6) 2021 - returned wire has a broken core wire.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM
• 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: 12210698
• Report Number: 3006260740-2021-02891
• Device Sequence Number: 12007241
• 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): 07/03/2021

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: N/A
• Device Catalogue Number: 5593150
• Device Lot Number: REEX2165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/22/2021
• 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