MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN PORT; IMPLANTABLE PORT

Catalog Number UNK PORT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Swelling (2091); Thrombosis (2100); Neck Pain (2433)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not 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.(b)(4).

Event Description

It was reported that approximately one year ten months post port device implant, the patient allegedly experienced pain, swelling, and tenderness in the right neck area.It was further reported that the patient was hospitalized and imaging was performed, which demonstrated thrombus of the right internal jugular vein.Reportedly, the device was removed by dissection and the patient was discharged.The patient is reported as continuing to have neck pain from the healing process.

• Brand Name: UNKNOWN PORT
• 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: 9356082
• MDR Text Key: 167409729
• Report Number: 3006260740-2019-03639
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PORT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• 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
• Treatment: LEVONOX, HEPARIN, CLOUMADIN
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 67