MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA KIT 20CM; ACUTE DIALYSIS CATHETER

Catalog Number	5593200
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that the port at the needle tip cracked.When the device was connected to a syringe under negative pressure, leakage was detected.This report addresses one device.
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 a cracked introducer needle is inconclusive due to the state of the returned sample.One photograph of an introducer needle was returned for evaluation.An initial visual observation of the photograph showed the device held in hand by a clinician.No visible signs of a break, crack, or leak in the device could be discerned from the photograph.No additional damage or use residue was noted.Inspection of the returned photograph was insufficient to identify the alleged issue or a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: NIAGARA KIT 20CM
• Common Device Name: ACUTE DIALYSIS CATHETER
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24308306
• Report Number: 3006260740-2026-00743
• Device Sequence Number: 9471263
• Product Code: MPB
• UDI-Device Identifier: 00801741045578
• UDI-Public: (01)00801741045578(11)250222(17)271231(10)REKN0637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030268
• 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): 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 Catalogue Number: 5593200
• Device Lot Number: REKN0637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2025
• 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