MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI POWERPORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1709601
Medical Device Problem Codes	Defective Component (2292); Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three tunnelers were returned for evaluation.Two of the tunnelers were still in their respective sealed kits, the third tunneler was received with multiple bends along the shaft.The investigation is confirmed for incorrect component as the tunnelers included in the kits do not match the tunnelers that were intended to be included in the kit.Based upon the available information, the definitive root cause is unknown.The devices are labeled for single use.
Event or Problem Description
This report summarizes three (3) malfunctions.A review of the reported information indicated that model 1709601 implanted port allegedly experienced a defective component and incorrect component.This information was received from one source.The malfunctions did not involve patients as there was no patient contact.The patients' age, weight, and gender were not provided.

• Brand Name: TI POWERPORT
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8805470
• Report Number: 3006260740-2019-02049
• Device Sequence Number: 10876967
• Product Code: LJT
• UDI-Device Identifier: 00801741026737
• UDI-Public: (01)00801741026737
• 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): 07/18/2019

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: 1709601
• Device Catalogue Number: 1709601
• Device Lot Number: RECU1601
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1