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

Model Number	1709601
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were returned to bd for evaluation.The three malfunctions were confirmed for incorrect component.The investigation is confirmed the root cause was determined to be manufacturing related.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 1709601 implanted port allegedly experienced a component missing.This information was received from one source.These three malfunctions did not involve a patient with patient status unknown.The patient age, gender, and weight were not provided.
Additional Manufacturer Narrative
H10: the three devices were returned to bd for evaluation.A lot number was provided and a lot history review was performed.The three malfunctions were confirmed for incorrect component.The investigation is confirmed the root cause was determined to be supplier related.The devices are labeled for single use.
Event or Problem Description
This report summarizes three malfunctions.A review of the reported information indicated that model 1709601 implanted port allegedly experienced a component missing.This information was received from one source.These three malfunctions did not involve a patient.The patient age, gender, and weight were not provided.

• Brand Name: POWER PORT TI, 9.6 SI, INT WOSP, ATT, SL
• Common Device Name: IMPLANTED PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9211033
• Report Number: 3006260740-2019-03185
• Device Sequence Number: 13565289
• 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): 01/06/2020

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: 01/06/2020
• Patient Sequence Number: 1