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
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 1709601.Port & catheter, implanted, subcutaneous, intravascular allegedly had a defective component.This report was received from a single source.This event did not involve patient with no patient contact.Age, weight, and gender were not provided for the patient.
Additional Manufacturer Narrative
H.10.For the reported three malfunctions, three devices were returned for evaluation.The lot number for the malfunctions were provided; therefore, a lot history review was performed.The missing tip of the tunneler was confirmed for all devices.A definitive root cause could not be determined.The devices are labeled for single use.H10: h6 (device code: 2306 - component missing).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 1709601.Port & catheter, implanted, subcutaneous, intravascular allegedly had a defective component.This report was received from a single source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender were not provided for the patient.

• 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: 9210907
• Report Number: 3006260740-2019-03184
• Device Sequence Number: 11500894
• 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): 01/20/2020

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: 1709601
• Device Catalogue Number: 1709601
• Device Lot Number: RECU1601
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/20/2020
• Patient Sequence Number: 1