MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER PORT TI, 9.6 SI, INT WOSP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1709601
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review is not required, however it was requested.The device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.One tunneler was received, the sample was received with the device alone.The tunneler received did not match the dwg5167281, which is the tunneler that should be included in the kit specified.However, due to the kit being opened upon return it is unknown whether the wrong components could have been due to clinical or packaging return procedure.The device was used for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 1709601 port & catheter, implanted, subcutaneous, intravascular alleged difficulty during port placement because there was an incorrect tunneler in the kit.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patients age, weight and gender were not provided.

• Brand Name: POWER PORT TI, 9.6 SI, INT WOSP, ATT, SL
• 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: 8533127
• Report Number: 3006260740-2019-01084
• Device Sequence Number: 11224247
• 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): 04/19/2019

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: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1