MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "when inserting the catheter over the guide wire, it kinked subcutaneously together with the catheter.The catheter removed, leaving the guide wire in place (still correctly positioned intravascularly).Slightly stronger traction than normal was applied.Spiral from which the guide wire is made has stretched into a thin wire (spiral was twisted open)".11/09/2023 - additional information provided by bd rep as far as we can currently judge, there were no consequential damages.The catheter is in use.Only the wire was damaged, not the catheter.
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.
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 damaged guidewire is confirmed and was determined to be use related.The returned product was one 0.035 in.J-tip guidewire.An initial visual observation showed the core wires of the guidewire were broken, and the coiled wire was observed to be unraveled.Use residue was observed on the returned sample.A microscopic observation revealed the break sites of the core wires were tapered with mostly flat and granular surface textures.The weld tip of the smaller core wire was found to be broken off and missing.The distal and proximal weld tips of the guidewire were both observed to be present and intact.The characteristics observed on the returned guidewire are indicative of a tensile failure caused by excessive pulling forces on the guidewire.An examination of the wire structure revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer "when inserting the catheter over the guide wire, it kinked subcutaneously together with the catheter.The catheter removed, leaving the guide wire in place (still correctly positioned intravascularly).Slightly stronger traction than normal was applied.Spiral from which the guide wire is made has stretched into a thin wire (spiral was twisted open)." 11/09/2023 - additional information provided by bd rep as far as we can currently judge, there were no consequential damages.The catheter is in use.Only the wire was damaged, not the catheter.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18192963
• Report Number: 3006260740-2023-05303
• Device Sequence Number: 7322054
• Product Code: NIE
• UDI-Device Identifier: 00801741041914
• UDI-Public: (01)00801741041914
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K133456
• 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): 04/17/2024

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: 11/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 5608240
• Device Lot Number: REGW3272
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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