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

Model Number N/A

Device Problem Crack (1135)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported the puncture needle is ruptured at the end of the needle, and the puncture and catheterization cannot be successfully completed.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.The manufacturer has received the sample and will evaluate.Results are expected soon.

Manufacturer Narrative

H11: 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 leaking/damaged needle hub is confirmed; however, the exact cause is unknown.Three photographs of an 18 g introducer needle were returned for evaluation.An initial visual observation of the photographs showed a relatively large crack in the hub of the introducer needle.Use residue was observed on the sample in the returned photographs.While a crack in the hub of the introducer needle can be seen, it was not possible to determine a root cause of this damage from the returned photographs.Therefore, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.

Event Description

It was reported the puncture needle is ruptured at the end of the needle, and the puncture and catheterization cannot be successfully completed.No other information was provided.

• Brand Name: NIAGARA SLIMCATH DIALYSIS CATHETER KIT 12F X 20CM STRAIGHT SHORT-TERM DUAL-LUMEN
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18430358
• MDR Text Key: 332607994
• Report Number: 3006260740-2023-05975
• 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
• Report Date: 01/26/2024

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: REHR2999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 01/26/2024
• Supplement Dates FDA Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2023
• 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