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 Material Frayed (1262); Defective Component (2292)

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

Event Date 08/22/2023

Event Type  malfunction  

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 will evaluate.Results are expected soon.

Event Description

It was reported that on (b)(6), it was found that the guide wire was broken and the tube could not be placed.The customer replaced it with a new one and re-placed the tube.No other information was 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.

Event Description

It was reported that on august 22, it was found that the guide wire was broken and the tube could not be placed.The customer replaced it with a new one and re-placed the tube.No other information was provided.

Event Description

It was reported that on august 22, it was found that the guide wire was broken and the tube could not be placed.The customer replaced it with a new one and re-placed the tube.No other information was 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.Based on a review of this information, the following was concluded: the complaint of a damaged guidewire is confirmed; however, the root cause could not be determined.Three photographs of an introducer needle and guidewire were returned for evaluation.An initial visual observation of the photographs showed the introducer needle with the guidewire attached to it.The guidewire was unraveled, indicating the core wire was broken.Use residue was observed on the sample in the returned photographs.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17730569
• MDR Text Key: 323201773
• Report Number: 3006260740-2023-04055
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• 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: 01/22/2024

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: REGW3667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 09/06/2023; 01/22/2024
• Supplement Dates FDA Received: 09/20/2023; 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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