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

Model Number 5743690

Device Problems Material Opacification (1426); Stretched (1601); Material Protrusion/Extrusion (2979)

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

Event Date 01/04/2022

Event Type  malfunction  

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: the physical sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one hemosplit dialysis catheter implanted in a patient body.Both the extension legs of the catheter was found bulged.The venous extension leg was noted to have a slight emulsification proximal to the bifurcation, however the arterial extension leg was noted to be deformed and emulsified through-out.Therefore, the investigation is confirmed for the reported stretched, material protrusion and material opacification issues.A definitive root cause could not be determined based upon the 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: 11/2022).

Event Description

It was reported that during an ultrasound guided dialysis catheter placement procedure, a catheter was allegedly found to be swollen.The procedure was completed 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: the physical sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one hemosplit dialysis catheter implanted in a patient body.Both the extension legs of the catheter was found bulged.The venous extension leg was noted to have a slight emulsification proximal to the bifurcation, however the arterial extension leg was noted to be deformed and emulsified through-out.Therefore, the investigation is confirmed for the reported stretched, material protrusion and material opacification issues.A definitive root cause could not be determined based upon the 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: 11/2022).

Event Description

It was reported that during an ultrasound guided dialysis catheter placement procedure, a catheter was allegedly found to be swollen.The procedure was completed using another device.There was no reported patient injury.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13596926
• MDR Text Key: 286241894
• Report Number: 3006260740-2022-00459
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013263
• UDI-Public: (01)00801741013263
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K030020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2022

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 Model Number: 5743690
• Device Catalogue Number: 5743690
• Device Lot Number: REFN3281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2022
• Initial Date FDA Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• 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
• Patient Age: 79 YR
• Patient Sex: Female