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

Model Number	0600524
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The device was returned for evaluation and the investigation identified a break.A definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600524 chronic catheter allegedly experienced a break.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: HICKMAN S/L CATHETERS
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9200205
• Report Number: 3006260740-2019-03078
• Device Sequence Number: 14100582
• Product Code: LJS
• UDI-Device Identifier: 00801741051814
• UDI-Public: (01)00801741051814
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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
• Operator of Device: No Information
• Device Model Number: 0600524
• Device Catalogue Number: 0600524
• Device Lot Number: HUBV0714
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1