MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED); 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	09/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of refq1941 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 resistance was encountered when the guide wire was being removed.After the guide wire was removed completely, the helix part of the guide wire was detached for 20 cm.Ultrasound examination was conducted subsequently to rule out any residual of the guide wire in this patient.It was reported this occurred with two devices.This report addresses the first device.
Event or Problem Description
It was reported that resistance was encountered when the guide wire was being removed.After the guide wire was removed completely, the helix part of the guide wire was detached for 20 cm.Ultrasound examination was conducted subsequently to rule out any residual of the guide wire in this patient.It was reported this occurred with two devices.This report addresses the first device.Additional information received: was there any patient harm reported? no.Were any broken pieces left inside the patient? no pieces left inside patient.
Additional 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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed but the exact cause remains unknown.One photo sample of a guidewire extending from the proximal end of an introducer needle was provided for evaluation.Blood residue and evidence of use was noted.The guidewire segment visible was elongated and unraveled.The proximal tip of the wire appeared to be intact; however, the core wire could not be closely inspected.The distal end of the guidewire and needle are not visible and could not be inspected for additional damage.Based on the information provided, possible contributing factors include residue interference, retraction of the guidewire against the needle bevel, and kinked guidewire.Since the guidewire was observed to be frayed and elongated in the image provided, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.

• Brand Name: NIAGARA DIALYSIS CATHETER KIT 13.5F X 15CM (PRE-CURVED)
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15501091
• Report Number: 3006260740-2022-03785
• Device Sequence Number: 12083715
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090102
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 5594150
• Device Lot Number: REFQ1941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown