MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F

Model Number 5833690

Device Problems Fracture (1260); Material Frayed (1262); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for evaluation.The investigation is confirmed for guidewire stretched issue, failure to advance, break, and material frayed issue.A definitive root cause for the reported event could not be determined.The device is labeled for single use.(b)(4).

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5833690 dialysis catheter allegedly experienced fracture, material frayed, stretched and failure to advance.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, sex and weight were not provided.

Manufacturer Narrative

H10: the product code msd was determined to be ineligible for summary reporting and was submitted by mistake.The event is captured on mdr number 3006260740-2021-80022.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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model: 5833690 dialysis catheter allegedly experienced fracture, material frayed, stretched and failure to advance.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The patient age, sex and weight were not provided.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F
• Type of Device: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 11216695
• MDR Text Key: 228431900
• Report Number: 3006260740-2021-80016
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741013386
• UDI-Public: (01)00801741013386
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5833690
• Device Catalogue Number: 5833690
• Device Lot Number: REEN4877
• Date Manufacturer Received: 01/21/2021
• Patient Sequence Number: 1