MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HEMOSPLIT CATHETER; DIALYSIS CATHETER

Catalog Number 5733730

Device Problems Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)

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

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2024).H11: section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported that during a dialysis catheter placement procedure, the catheter was allegedly stuck in peel apart sheath.It was further reported that the catheter was allegedly kinked.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 23cm hemosplit d/l catheter kit with the following components were received: one 23cm hemosplit d/l catheter, one tunneler with a loaded protective sheath, one vessel dilator, two luer caps, one j-tip guidewire in a guidewire hoop, one 8fr dilator, one 12fr dilator, one used adhesive dressing and two peeled apart sheath shafts.In addition to the returned sample analysis, two electronic photos and one electronic image were provided for review.Gross visual, tactile and microscopic visual evaluations were performed.Both peeled apart sheath shafts reflected "bard" on their respective t-handle, so both were mismatched.Bends and twists were noted throughout both peeled apart sheath shafts.The catheter was gently stretched, and normal elasticity was observed throughout.No kinks were noted throughout.Therefore the investigation is unconfirmed for the reported deformation issue.Furthermore the image review shows the catheter could not be passed successfully and became stuck at some point within the sheath.Therefore the investigation is confirmed for the reported reported failure to advance and physical resistance issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.(expiry date: 07/2024) section a through f ¿ the information provided by bd represents all 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.

Event Description

It was reported that during the preparation of a dialysis catheter placement procedure, the catheter was allegedly stuck in pill apart sheath.It was further reported that the catheter was allegedly kinked.The procedure was completed using another device.There was no patient contact.

• Brand Name: HEMOSPLIT CATHETER
• 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: 18215326
• MDR Text Key: 329084161
• Report Number: 3006260740-2023-05364
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741000454
• UDI-Public: (01)00801741000454
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 02/12/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 5733730
• Device Lot Number: REGX1237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2022
• 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