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

Model Number	0600040
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This event summarizes one malfunction.The information reviewed indicated that model 0600040 chronic catheter allegedly experienced a split and leaked.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.
Additional Manufacturer Narrative
The lot number for the malfunction was not provided; therefore a lot history will not be performed.The device was returned and fluid leak was confirmed.The definitive root cause could not be determined based upon available information.The device was labeled for single use.
Event or Problem Description
This event summarizes one malfunction.The information reviewed indicated that model 0600040 chronic catheter allegedly experienced a split and leaked.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.

• 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: 9199607
• Report Number: 3006260740-2019-03053
• Device Sequence Number: 3031049
• Product Code: LJS
• UDI-Device Identifier: 00801741036309
• UDI-Public: (01)00801741036309
• 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,Followup
• Report Date (Section B): 01/06/2020

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: 0600040
• Device Catalogue Number: 0600040
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1