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

Model Number	0600630
Medical Device Problem Codes	Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one reported events, the device was returned to bd and evaluated.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 0600520 chronic catheter allegedly ruptured which was evident by a popping sound.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender was not provided.
Additional Manufacturer Narrative
Of the 1 devices, lot number was provided, and lot history review was performed.Visual, microscopic, tactile and functional evaluations were performed.The investigation is confirmed for external leak, more specifically an external burst., as a c-shaped split was observed just proximal to the bifurcation on the red-hub extension leg which is consistent with a burst.A root cause has not been determined.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 0600520 chronic catheter experienced fluid leak.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender was not provided.

• Brand Name: HICKMAN D/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: 8529589
• Report Number: 3006260740-2019-01010
• Device Sequence Number: 19522584
• Product Code: LJS
• UDI-Device Identifier: 00801741051944
• UDI-Public: (01)00801741051944
• 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): 07/23/2019

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: 0600630
• Device Catalogue Number: 0600630
• Device Lot Number: HUCR1207
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1