MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICK HEMO 13.5FR CATH ONLY; DIALYSIS CATHETER

Model Number	0600490
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the event is unknown, therefore the manufacturing review could not be conducted.The device has not been returned for evaluation; therefore, the investigation is inconclusive for failure to infuse as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model 0600490 dialysis catheter experienced a failure to infuse.This event was reported from a single source.This event involved a patient with no reported injury.The patient¿s age, weight, and sex were not provided.

• Brand Name: HICK HEMO 13.5FR CATH ONLY
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533353
• Report Number: 3006260740-2019-01102
• Device Sequence Number: 16540806
• Product Code: LJS
• UDI-Device Identifier: 00801741037498
• UDI-Public: (01)00801741037498
• 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): 04/19/2019

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: 0600490
• Device Catalogue Number: 0600490
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1