MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERFLOW 16G IV PORT INTER; APHERESIS PORT

Model Number A710962

Device Problems Migration or Expulsion of Device (1395); Suction Problem (2170); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 08/18/2019

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.Journal article citation: gray, k.L., steidley, i.G., benson, h.L., pearce, c.L., bachman, a.M., and adamski, j.(2019, september 4).Implementation and 2-year outcomes of the first fda-approved implantable apheresis vascular access device.Retrieved from https://onlinelibrary.Wiley.Com/doi/pdf/10.1111/trf.15512.

Event Description

It was reported in an article from the journal of transfusion titled " implementation and 2-year outcomes of the first fda-approved implantable apheresis vascular access device " that a total of eighteen patients underwent apheresis treatment during the study period.Two patients experienced infection as the blood culture came positive, therefore the ports were removed and the infection was treated with antibiotic and supportive therapy.In one patient, the catheter was unable to aspirated and even after administrating alteplase the line did not clear the obstructed flow; dye study confirmed that the catheter tip migrated into the azygous vein and this prevented the use of the port.Catheter tip migrated in another patient but due to completion of the treatment, repositioning was not performed.The status of the patients was not provided.

• Brand Name: POWERFLOW 16G IV PORT INTER
• Type of Device: APHERESIS 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: 9305765
• MDR Text Key: 165997490
• Report Number: 3006260740-2019-03511
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• 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