MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (SHORT-TERM) DL; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Component Incompatible (1108); Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Customer reported after the guidewire enters the puncture needle, it cannot enter the blood vessel, and the needle and guidewire are withdrawn, and the guidewire cannot be removed from the puncture needle.No other information provided.

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 manufacturer has received the sample and is pending evaluation.Results are expected soon.

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.

Event Description

Customer reported after the guidewire enters the puncture needle, it cannot enter the blood vessel, and the needle and guidewire are withdrawn, and the guidewire cannot be removed from the puncture needle.No other information provided.

Event Description

Customer reported after the guidewire enters the puncture needle, it cannot enter the blood vessel, and the needle and guidewire are withdrawn, and the guidewire cannot be removed from the puncture needle.No other information provided.

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 complaint of a damaged guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was two photographs which depicted one stainless steel j-tip guidewire.The wire was inserted into its plastic hoop.The distal end of the wire was visible protruding from the hoop.The core wire was broken and the coil wire was elongated.The weld tip was present and remained attached to the coil wire.Damage was evident in the photographs; however, inspection of the photographs was insufficient to identify the cause of the damage.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM (STRAIGHT) (SHORT-TERM) DL
• Type of Device: 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18279801
• MDR Text Key: 330816029
• Report Number: 3006260740-2023-05545
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: REGQ1654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/05/2024; 02/16/2024
• Supplement Dates FDA Received: 01/11/2024; 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other