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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult dilator insertion was confirmed; however, the root cause was not identified.The product returned for evaluation was three photographs which depicted dialysis catheter kit components.The first photograph depicted the tip of a dualator vessel dilator.The tip exhibited deformation and discoloration.Blood residue was visible in the photograph.The second photograph depicted a portion of the dialysis catheter and guidewire during the insertion procedure.A sharp bend was observed in the guidewire between the overlaid catheter and the insertion site.The third photograph depicted two vessel dilator tips.The one on the left exhibited discoloration and deformation comprising outward flaring edges.The right side one appeared undamaged and may have been included as a reference image.The damaged dilators in the first and third images appeared to be different samples suggesting that two devices may have been damaged during the procedure.The vessel dilator tip deformation observed in the first and third photograph and the guidewire deformation observed in the second were consistent with damaged caused by traumatic contact between the wire and the dilators during device placement.Such damage can occur if the insertion angle is steep and if resistance is encountered when advancing the dilators over the wire.While the observations were consistent with damage caused during device insertion, inspection of the photographs did not allow for thorough examination of the components.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.A lot history review (lhr) of redp0004 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 china.
Event or Problem Description
It was reported that during catheter insertion, the guide wire got stuck in introducer needle, unable to be pulled out.The vascular sheath was defective.The same problem occurred with two products.The procedure went smoothly after switching to a third one.(b)(6) 2020, per evaluation findings, samples exhibited deformation comprising outward flaring edges.This report addresses the first device.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM)
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10870004
• Report Number: 3006260740-2020-03583
• Device Sequence Number: 3315807
• Product Code: MPB
• UDI-Device Identifier: 00801741045370
• UDI-Public: (01)00801741045370
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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 Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5553240
• Device Lot Number: REDP0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 48