MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH; CATHETER, HEMODIALYSIS, IMPLANTABLE

Model Number	N/A
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guidewire stuck with needle.No patient injury was reported.No further details were provided.03/12/2026: the returned device exhibited a bent guidewire.
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 complaint of difficulty removing the introducer needle from the guidewire is confirmed and was determined to be related to use of the product.One pink 18 ga introducer needle and one j-tip guidewire were returned for evaluation.An initial visual observation of the returned guidewire and introducer needle showed blood use residues along the returned devices.The proximal end of the guidewire was observed to be bent.A functional test of carefully and forcefully removing the guidewire from the complainant introducer needle revealed the guidewire could be removed with some damage to the core wire of the guidewire.A functional test of attempting to insert the distal end of the complainant guidewire into a non-complainant 18 ga introducer needle revealed the guidewire would not pass over the blood residues observed at the distal end of the device.A functional test of attempting to insert a non-complainant 0.038 in.Guidewire into the complainant introducer needle revealed the guidewire would stick inside the introducer needle.The guidewire passed with some force, and use residues exited the introducer needle, allowing the non-complainant guidewire to pass easily through the complainant introducer needle.A microscopic observation revealed abundant blood residues along the guidewire and introducer needle.The blood appeared to be coagulated along the guidewire causing resistance in the introducer needle.This failure was determined to be caused by excessive use residues inside the introducer needle and along the guidewire.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: NIAGARA SLIM-CATH
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTABLE
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24734793
• Report Number: 3006260740-2026-02114
• Device Sequence Number: 10191780
• Product Code: MPB
• UDI-Device Identifier: 00801741045356
• UDI-Public: (01)00801741045356(11)250204(17)271130(10)REJZ1979
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026

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 Model Number: N/A
• Device Catalogue Number: 5553150
• Device Lot Number: REJZ1979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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