MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 44012

Patient Problems Failure of Implant (1924); Increased Sensitivity (4538); Implant Pain (4561)

Event Date 08/15/2023

Event Type  malfunction  

Event Description

Patient in clinic receiving chemotherapy.Implanted port-a-cath (pac) lower right chest lateral to armpit accessed with 20-gauge 3/4-inch huber needle, skin intact; port accessed per protocol using aseptic technique, brisk blood returned achieved after 2nd rn assessed placement and flush performed without discomfort, easily with brisk blood return.Patient is able to taste saline, needle secured with tegaderm dressing.Kvo fluids initiated via pac and pre-meds administered.Premeds given per mar.  chemotherapy administered subsequently per orders; oxaliplatin and leucovorin administered concurrently per protocol. patient tolerated infusion without any adverse side effects.Post oxaliplatin and leukovorin, patient noted that 'port' was 'hurting'.Port assessed, no visible signs of infection, port flushes easily, patient able to taste/smell, no blood return noted on flush.On further reassessment and removal of tegaderm, patient states tenderness above right breast without redness, streaking or warmth.Treatment discontinued, patient to be released to interventional radiology for port dye study to evaluate integrity of port access.Needle left in place for ir use/flouro study.I was informed by my nurse that patient was sent over to radiology for the port patency check.We do not have the final report, but radiology team has called my nurse explaining that patient is in lot of pain with mediport area.So i have requested my nurse to inform the radiology team to send the patient to the er to make sure she is not having any thrombus in the mediport area.Also if the mediport is not functioning properly that has to be replaced, she got to be admitted and has to be port replaced.Patient had mediport replaced days after.

• Brand Name: BIOFLO
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): ANGIODYNAMICS; 24 native dr; queensbury NY 12804
• MDR Report Key: 18282519
• MDR Text Key: 329939837
• Report Number: 18282519
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 44012
• Device Lot Number: 5765089
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/05/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Race: White