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

Model Number	0601620
Medical Device Problem Codes	Burst Container or Vessel (1074); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.Based on information in the sample evaluation: one 6.6fr broviac extension leg was returned for evaluation.Visual, tactual, functional and microscopic evaluations were performed.The investigation is confirmed for a fracture, more specifically, a burst in the catheter leg.The sample was received with one extension leg and one needleless infusion hub.An s-shaped split was observed just distal to the first catheter diameter narrowing.Microscopic evaluation revealed more detail on the split.The edges of the split were observed to be smooth and finely granular.The center of the break surface was observed to be rough and granular.A portion from one break surface was observed to project to the opposite surface.The damage to the inside of the tube at the burst site appeared to consist of longitudinal shredding or similar from unknown causes; it is unknown if this damage was resultant from or contributory to the burst.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model 0601620 chronic catheter repair kit allegedly experienced a burst and a fracture.This report was received from one source.The device was used inside the (b)(6) year-old male patient.There was no reported patient injury.

• Brand Name: 203 REPAIR 1.0MM-WHITE
• Common Device Name: CHRONIC CATHETER REPAIR KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8528421
• Report Number: 3006260740-2019-00958
• Device Sequence Number: 1899798
• 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