MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT VUE IMPLANTABLE PORT, CHRONOFLEX, SINGLE-LUMEN, 8F; IMPLANTED PORTS

Model Number	1708062
Medical Device Problem Codes	Difficult to Flush (1251); Obstruction of Flow (2423); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For one malfunction, the device was returned to bd and is pending evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 1708062 implanted ports allegedly experienced obstruction of flow.This information was received from one source.This malfunction involved a patient with no consequences.The patient is a female but the age and weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 1708062 implanted ports allegedly experienced obstruction of flow.This information was received from one source.This malfunction involved a patient with no consequences.The patient was a female; however, the age and weight was not provided.
Additional Manufacturer Narrative
H10: the lot number for the device was provided and a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation and an electronic photo was provided for review.The investigation of the reported malfunction identified obstruction of flow.Based upon the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.H11: b5, h6 (results, conclusion).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 one malfunction.A review of the reported information indicated that model 1708062 implanted ports allegedly experienced difficult to flush and material protrusion.This information was received from one source.This malfunction involved a patient with no consequences.The patient was a female; however, the age and weight were not provided.
Additional Manufacturer Narrative
H10: the lot number for the device was provided and a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation and an electronic photo was provided for review.The investigation is confirmed for material protrusion/extrusion; however, the investigation is inconclusive for the reported difficult to flush issue.Based upon the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.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.

• Brand Name: POWERPORT VUE IMPLANTABLE PORT, CHRONOFLEX, SINGLE-LUMEN, 8F
• Common Device Name: IMPLANTED PORTS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10280478
• Report Number: 3006260740-2020-02452
• Device Sequence Number: 19432696
• Product Code: LJT
• UDI-Device Identifier: 00801741026645
• UDI-Public: (01)00801741026645
• 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,Followup
• Report Date (Section B): 01/19/2021

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: 1708062
• Device Catalogue Number: 1708062
• Device Lot Number: RECW0342
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020; 12/31/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 10/14/2020; 01/19/2021
• Patient Sequence Number: 1