MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PORT; BIOFLO 6F SINGLE PLASTIC FILLED; NON-VALVED

Catalog Number	44012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Implant Pain (4561)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
Angiodynamics received a user medwatch (b)(4).A risk manager reported an issue with a bioflo 6f single plastic filled; non-valved.The following was reported: "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.".
Additional Manufacturer Narrative
Event date was updated from 10/15/2023 to 8/15/2023.The customer's reported complaint description of port was defective cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the dfu (14600304-01) provided with this port device contains the following precautions: precautions: · carefully read and follow all instructions prior to use.· only licensed health care practitioners should insert, manipulate, and remove these devices.Intended use/ indications for use: the bioflo port with endexo technology, bioflo dual port with endexo technology and the bioflo port with endexo and pasv valve technology are indicated for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products.The device is also indicated for blood specimen withdrawal.Adverse events: drug extravasation, hematoma, implantation site necrosis or infection, catheter occlusion, malposition, dislodgment, fragmentation, migration, disconnection or rupture catheter occlusion or breakage caused by pinching between clavicle and first rib.Catheter to port connection: 4.Advance catheter over port stem to the midway point.5.Orient the snap lock connector such that arrow marking points in the direction of port.Advance snap lock connector until it engages with tactile and/or audible feedback.Note: to ensure proper assembly of port and snaplock connector, a minimal gap (less than 0.5 mm) is expected.Precaution: prior to advancing the snap lock connector, ensure that the catheter is properly positioned.A catheter not advanced to the proper region may not seat securely and lead to dislodgement and extravasation.The catheter must be straight with no sign of kinking.A slight pull on the catheter is sufficient to straighten it.Advancing the snap lock over a kinked catheter may damage the catheter.Contraindications: catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: BIOFLO PORT
• Common Device Name: BIOFLO 6F SINGLE PLASTIC FILLED; NON-VALVED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 18357653
• Report Number: 1317056-2023-00177
• Device Sequence Number: 15177390
• Product Code: LJT
• UDI-Device Identifier: H965440120
• UDI-Public: H965440120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131694
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: 44012
• Device Lot Number: 5765089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female