MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM) (DUAL; NIAGARA NON-IMPLANTED BLOOD ACCESS DEVICE

Catalog Number	5553240
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/26/2016
Type of Reportable Event	Malfunction
Additional 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 following were reviewed as part of this investigation: patient severity, trend 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 damaged guidewire was confirmed and the cause appeared to be use-related.The product returned for evaluation was one j-tip guidewire and one 18ga introducer needle.The wire was inlaid through the needle shaft and was stuck.Blood residue was observed on the wire and within the needle hub.The inner core wire was broken and the outer coil wire was elongated.Following removal of the guidewire, a mass of tissue residue was observed adhered to the j-tip region.Microscopic inspection of the needle bevel revealed light mechanical damage along the proximal edge.Microscopic inspection of the inner core wire revealed material necking in the vicinity of the break.The break surface exhibited a dully granular texture.The break profile appeared tapered.The wire break characteristics were consistent with damage caused by tensile stress.The tissue residue and introducer needle bevel damage indicated that an attempt was made to withdraw the wire through the needle shaft.That attempt drew tissue into the needle shaft which caused the wire to become stuck.Subsequent pulling resulted in the observed break in the wire.A lot history review (lhr) of rezg0448 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during withdrawal of the guidewire, it was stuck to the puncture needle.The physician then noticed that the guidewire started to ravel, causing the mandrin and the puncture needle to be removed at same time.They took another catheter and restarted the procedure completely.Procedure was completed successfully.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM) (DUAL
• Common Device Name: NIAGARA NON-IMPLANTED BLOOD ACCESS DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5512206
• Report Number: 3006260740-2016-00115
• Device Sequence Number: 191702
• Product Code: MPB
• UDI-Device Identifier: 00801741045370
• UDI-Public: (01)00801741045370(17)180628(10)REZG0448
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2016

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 Expiration Date: 06/28/2018
• Device Catalogue Number: 5553240
• Device Lot Number: REZG0448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 03/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR