MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6.6F BROVIAC CV CATHETERS 1.0MM LUMEN (WHITE ADAPTER) REPAIR KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0601620
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.The device has been returned for evaluation; no break was noted to the returned catheter.Therefore, the investigation is unconfirmed to the reported catheter dislodgement and confirmed for hub detachment.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 0601620 chronic catheter repair experienced a device detachment and a device dislodged or dislocated.This event was reported from a single source.This event involved a patient with no reported injury.The patient was reported as a (b)(6) year old male whose weight was not provided.

• Brand Name: 6.6F BROVIAC CV CATHETERS 1.0MM LUMEN (WHITE ADAPTER) REPAIR KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8528412
• Report Number: 3006260740-2019-00965
• Device Sequence Number: 1883803
• 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): 04/18/2019

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: 0601620
• Device Catalogue Number: 0601620
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1