MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. UNKNOWN IMPLANTED APHERESIS PORT; SUBCUTANEOUS IMPLANTED APHERESIS PORT

Catalog Number UNK PORT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records 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.The information provided by bard 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 bard.

Event Description

It was reported when port was accessed the port had great blood return and flush well; however, when they hook up the patient to the amicus tubing and try to draw immediately the inlet pressure goes to red.The lines were switched and it does the same thing.Dye study was normal.It is taking 9 hours to do the apheresis procedure.

• Brand Name: UNKNOWN IMPLANTED APHERESIS PORT
• Type of Device: SUBCUTANEOUS IMPLANTED APHERESIS PORT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• 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 ; 605 n. 5600 w.; salt lake city, UT 84116 ; 4803032689
• MDR Report Key: 7470372
• MDR Text Key: 106860458
• Report Number: 2020394-2018-00510
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK PORT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/06/2018
• 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