MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
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.
Event or Problem Description
It was reported by the customer, there was a micro-crack just before the plastic lumen begins and wasn't discovered until bedside crrt was turned on and the pressure began.No other information was 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 leaking extension tubing was confirmed.The product returned for evaluation was one 24 cm duoglide dialysis catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue occurs due to cyclic kinking of the tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product sample was evaluated and a split was observed at the distal end of the blue lumen extension tubing.The extension tubing split contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: ¿ damage which was circumferentially aligned.¿ fracture edges which were rounded and polished due to repeated material wear.¿ 'c' shaped impressions leading into the fracture site which are consistent with material.Buckling due to movement which caused the fracture edges to be pressed together.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer, there was a micro-crack just before the plastic lumen begins and wasn't discovered until bedside crrt was turned on and the pressure began.No other information was provided.

• Brand Name: DUOGLIDE SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER
• Common Device Name: 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19356178
• Report Number: 3006260740-2024-02475
• Device Sequence Number: 6342237
• Product Code: MPB
• UDI-Device Identifier: 00801741042119
• UDI-Public: (01)00801741042119
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 5625240
• Device Lot Number: REHX0837
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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