MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM) DL; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported by the customer the eve of november 22, the doctor placed an indwelling hemodialysis catheter for the patient and found that the puncture point was ruptured and could not be used, resulting in another set of tubes being dismantled and re-instilled.No other information provided.
Event or Problem Description
It was reported by the customer the eve of november 22, the doctor placed an indwelling hemodialysis catheter for the patient and found that the puncture point was ruptured and could not be used, resulting in another set of tubes being dismantled and re-instilled.No other information provided.
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 connector was confirmed but the exact cause remains unknown.The product returned for evaluation was one 18 ga introducer needle.The returned product sample was evaluated and the luer connector was observed to be cracked.The fracture features were consistent with outward radiating forces originating within the luer hub orifice, and the characteristics observed which supported this type of failure included: ¿ a crack was observed which was longitudinally aligned.¿ multiple superficial cracks were also seen surrounding the primary damage and were also longitudinally aligned.¿ functional testing of infusion revealed a leak(s) emanating from the crack(s).¿ functional testing of aspiration showed that air was drawn into the syringe with test water.It was determined that the forceful insertion of a connecting device may have contributed to the observed damage; however, attempts to replicate this type of failure were unsuccessful which suggested that additional unidentified contributing factors may have also been involved.Consequently, the event was classified as cause unknown.H3 other text : evaluation findings in section h:11.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 24CM (STRAIGHT) (SHORT-TERM) DL
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, 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: 18314871
• Report Number: 3006260740-2023-05672
• Device Sequence Number: 20371581
• Product Code: MPB
• UDI-Device Identifier: 00801741045370
• UDI-Public: (01)00801741045370
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2024

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5553240
• Device Lot Number: REGS0633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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