MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SMALL VENOUS IMPLANTED PORT; IMPLANTED PORTS

Model Number	0602290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
New information received determined this event is reportable as a serious injury.Therefore, this event is being changed from vmsr to an mdr reportable event as a serious injury pursuant to 21 cfr 803.As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2023).
Event or Problem Description
It was reported that some time post port device implant, the port was removed and replaced.Allegedly, the patient had an infection.The procedure was completed using another device.The outcome of the patient is unknown.

• Brand Name: SMALL VENOUS IMPLANTED PORT
• Common Device Name: IMPLANTED PORTS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10587479
• Report Number: 3006260740-2020-03381
• Device Sequence Number: 2822984
• Product Code: LJT
• UDI-Device Identifier: 00801741025617
• UDI-Public: (01)00801741025617
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0602290
• Device Catalogue Number: 0602290
• Device Lot Number: REDR1991
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Weight: 73