MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT TI ISP, 8 FR CHRONOFLEX, MI W SUTURE PLUG, SL; IMPLANTABLE PORT

Model Number	1708050
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for the break and fracture as no objective evidence has been provided to confirm any alleged deficiency with the device.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 malfunction.A review of the reported information indicated that model 1708050 implantable port allegedly experienced a fracture and break.This information was received from one source.The malfunction did not involve a patient.Therefore, the patient¿s age, weight, and gender were not provided.

• Brand Name: POWERPORT TI ISP, 8 FR CHRONOFLEX, MI W SUTURE PLUG, SL
• Common Device Name: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9960523
• Report Number: 3006260740-2020-01298
• Device Sequence Number: 2808233
• Product Code: LJT
• UDI-Device Identifier: 00801741026591
• UDI-Public: (01)00801741026591
• 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): 04/14/2020

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: 1708050
• Device Catalogue Number: 1708050
• Device Lot Number: REDZ2298
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1