MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT MRI ISP, 8FR CHRONOFLEX, SUTURE PLUG, ATTACHABLE, SL; IMPLANTABLE PORT

Model Number 1808060

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erythema (1840); Unspecified Infection (1930); Reaction (2414)

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

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.(expiration date: 04/2021), (b)(4).

Event Description

It was reported that approximately twenty days post port device implant, the patient allegedly experienced symptoms of itching, redness, burning, and swelling over the port body.It was further reported that blood cultures were performed and results were positive for an infection.Additionally, antibiotics and antihistamine were administered and the port device was removed.Reportedly, the patient was recommended to see a specialist for the alleged symptoms and infection.The patient status is unknown post medication administration and port device removal.

• Brand Name: POWERPORT MRI ISP, 8FR CHRONOFLEX, SUTURE PLUG, ATTACHABLE, SL
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9234029
• MDR Text Key: 163836933
• Report Number: 3006260740-2019-03311
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027031
• UDI-Public: (01)00801741027031
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/24/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1808060
• Device Catalogue Number: 1808060
• Device Lot Number: REDT3121
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention