MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number ARROW SLIM MEDIPORT

Device Problems Disassembly (1168); Misassembled (1398); Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 01/29/2016

Event Type  malfunction  

Event Description

These ports have a design flaw that allows them to be assembled backward.The port was assembled backward and came apart inside the patient causing the patient to need another procedure to remove the dislodged piece and to have a new port placed.Upon reviewing all the cases, we did with this port, we found a total of four patients who had the device put in backwards.Two patients had surgery to replace their port.The other two patients have so far declined a replacement port as they were placed a year ago and there is likely scar tissue holding them together.

• Brand Name: ARROW
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 7582540
• MDR Text Key: 110500223
• Report Number: 7582540
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: ARROW SLIM MEDIPORT
• Device Lot Number: 17030132
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR