MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN S/L CATHETERS; CHRONIC CATHETER

Model Number 0600540

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided; therefore a lot history review will not be performed.The device was not returned for evaluation; therefore the investigation is inconclusive as no objective evidence was provided for review.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that after placement of model 0600540 chronic catheter, the patient experienced a reaction to the device.The information was received from one source.The malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• Brand Name: HICKMAN S/L CATHETERS
• Type of Device: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9965732
• MDR Text Key: 195245851
• Report Number: 3006260740-2020-01332
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051821
• UDI-Public: (01)00801741051821
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0600540
• Device Catalogue Number: 0600540
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1