MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F

Model Number 5733690

Device Problems Fracture (1260); Difficult to Remove (1528); Stretched (1601); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 19cm hemosplit d/l catheter with a loaded protective sheath, one tunneler, one 15fr peel-apart sheath and vessel dilator, one 8fr dilator, one 12fr dilator, two end caps and one j-tip guidewire in a guidewire hoop loaded into an introducer needle were returned for evaluation.Gross, microscopic visual, dimensional evaluation and functional testing were performed.In addition to the returned physical sample, one electronic photo was provided for review.The photo shows one j-tip guidewire in a guidewire hoop loaded into an introducer needle.The distal end of the guidewire was noted to be bent.However, the investigation is inconclusive for the reported difficult to remove and physical resistance issues as the exact circumstances at the time of reported event cannot be confirmed.The investigation is confirmed for the identified fracture, stretched and deformation issues as the flat core wire was noted to have a complete break within the guidewire coils and a portion of the guidewire, proximal to the distal tip was uncoiled.Furthermore, the distal end of the guidewire was noted to be bent.Based on the measurements recorded during sample evaluation and applicable drawings, no measurements recorded could be confirmed to be out of tolerance.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.(expiry date: 06/2023).

Event Description

It was reported that during a catheter placement procedure, the wire allegedly difficult to remove.Reportedly, both wire and introducer removed together.The procedure was completed by using another device.There was no reported patient injury.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F
• Type of Device: 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15938399
• MDR Text Key: 308067379
• Report Number: 3006260740-2022-05625
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013096
• UDI-Public: (01)00801741013096
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5733690
• Device Catalogue Number: 5733690
• Device Lot Number: REFW0804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1