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 Codes	Defective Component (2292); Component Missing (2306)
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 been returned for evaluation; missing tip was noted on the tunneler with all three powerport kits.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 malfunctions.A review of the reported information indicated that the tip of the tunneler was allegedly missing from a model 1709601 port & catheter.This information was received from a single source.There was no patient contact.The patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
For this event, the lot number was provided and a lot history review was performed.Of the 3 reported malfunctions, 3 devices were returned for evaluation.The investigation is confirmed for incorrect component.The root cause was determined to be manufacturing related.The device was labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that the tip of the tunneler was allegedly missing from a model 1709601 port & catheter.This information was received from a single source.There was no patient contact.The patient 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: 8809003
• Report Number: 3006260740-2019-02070
• Device Sequence Number: 13533123
• 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,Followup
• Report Date (Section B): 10/10/2019

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
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Supplement Report FDA Received Date: 10/10/2019
• Patient Sequence Number: 1