MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 203 REPAIR 1.0MM-WHITE; ONIC CATHETER REPAIR KIT

Model Number	0601620
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was 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 device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0601620.Chronic catheter repair kit allegedly experience obstruction of flow.This report was received from a single source.This event did involve patient with no patient consequences.Age, weight, and gender were not provided for the patient.

• Brand Name: 203 REPAIR 1.0MM-WHITE
• Common Device Name: ONIC CATHETER REPAIR KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9595878
• Report Number: 3006260740-2020-00121
• Device Sequence Number: 11437254
• Product Code: LJS
• UDI-Device Identifier: 00801741074479
• UDI-Public: (01)00801741074479
• 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): 01/16/2020

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: 0601620
• Device Catalogue Number: 0601620
• Device Lot Number: REBV1651
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1