MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMO CATH 40 CM & PIK; DIALYSIS CATHETER

Model Number	0600690
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the three reported complaints, the lot numbers for the device were provided, a manufacturing review will be performed.The samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The device is labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 0600690.Dialysis catheter allegedly dislodged and dislocated.These reports were received from various sources.All three events had no reported patient injury.Age, weight, and gender were not provided for the patient.

• Brand Name: HEMO CATH 40 CM & PIK
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8799407
• Report Number: 3006260740-2019-01981
• Device Sequence Number: 11472923
• Product Code: LJS
• UDI-Device Identifier: 00801741037535
• UDI-Public: (01)00801741037535
• 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): 07/17/2019

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: 0600690
• Device Catalogue Number: 0600690
• Device Lot Number: RECV3134, RECU0969
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1