MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLINE 6FR TL; CHRONIC CATHETER

Model Number	0730615
Medical Device Problem Code	Fracture (1260)
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 not returned, a lot history review could not be performed.The device was not returned to the manufacturer for evaluation; however, a photo was provided.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0730615 chronic catheter allegedly experienced fracture.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and sex were not provided.
Additional Manufacturer Narrative
As the lot number for the device was not provided, a lot history review could not be performed.The device was not returned to the manufacturer for evaluation; however, photos were provided for review.The investigation is confirmed for the fracture problem.The definitive root cause could not be established.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0730615 chronic catheter allegedly experienced fracture.This information was received from one source.One patient was involved with no patient consequences.Age, weight, and sex were not provided.

• Brand Name: POWERLINE 6FR TL
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9960426
• Report Number: 3006260740-2020-01289
• Device Sequence Number: 2377787
• Product Code: LJS
• UDI-Device Identifier: 00801741036637
• UDI-Public: (01)00801741036637
• 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,Followup
• Report Date (Section B): 07/22/2020

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: 0730615
• Device Catalogue Number: 0730615
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 04/14/2020
• Supplement Report FDA Received Date: 07/22/2020
• Patient Sequence Number: 1