MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO; PICC CONVENIENCE KIT

Model Number	60M701101
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A spectrum distributor reported an end user experienced an issue when using a can 4f sl bioflo pasv picc - nursing tray, calgary regional health authority.Prior to insertion, the picc was not wiped with any cleaning solution and the markers were visible after two hours of being placed.The patient had the picc inserted however, the tip was malpositioned in her right internal jugular (ij).The picc was left over the weekend to see if it would descend into the superior vena cava (svc).When she was reassessed, it was observed that the cm marking notches and every 5cm number indicators could not be seen past the 4cm mark.The plan was made to exchange the picc to a midline.When the picc was removed, it was noted that many of the cm markings were difficult to see and the written number at every 5cm was "erased" and unable to be seen.It was reported that the "missing" markers were located outside of the patient's skin and within the blood stream.
Additional Manufacturer Narrative
No unopened picc product package was returned to angiodynamics for evaluation, however, the customer did provide a picture showing the depth markings on the catheter tubing after the 2cm markings that were faded/missing and difficult to visualize.The customer's reported complaint description of catheter tubing was missing some depth markings after the catheter was removed from the patient was confirmed based on picture provided, however, no complaint sample was returned.Without receiving unopened product for evaluation, we are unable to definitively determine a root cause for this incident.Potential root cause is manufacturing non-conformance in applying depth markings to the catheter tubing, markings removed during preparation of the procedure (e.G.Exposure to chemicals) and/or patient blood chemistry.Dhr review for the indicated packaging/picc assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.There have been no other reported complaints for the indicated packaging/picc assembly lots for similar catheter markings illegible issue, as such, this is deemed to be an isolated incident for this picc product lots.Labeling review: the dfu that is supplied with the bioflo picc device contains the following statements: intended use/indications for use: the bioflo picc with endexo and pasv valve technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.Warnings: do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.Precautions: carefully read all instructions prior to insertion, care or use.Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.Do not use sharp instruments near the extension tubes or catheter shaft.It is recommended that institutional protocols be considered for all aspects of catheter use consistent with the instructions provided herein.Do not use scissors to remove the dressing, as this may possibly cut or damage the catheter.Prior to dressing the catheter and access site, inspect both to assure that they are completely dry of isopropyl alcohol or acetone based cleansing agents.To avoid pooling of an agent, do not fully insert catheter up to suture wing.Do not attempt to repair the catheter.If breaks or leaks are apparent in the catheter, remove the catheter immediately.Patients must be educated regarding the care and maintenance of their picc.The healthcare provider is responsible for this patient instruction.Potential complications/adverse events: air embolism, bleeding, infection, extravasation/infiltration of infusate.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.

• Brand Name: BIOFLO
• Common Device Name: PICC CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: ashleigh ashleigh garcia ; 50 main street; suite 1000; white plains, NY 10606 ; 8134543296
• MDR Report Key: 23851355
• Report Number: 1319211-2025-00052
• Device Sequence Number: 9836153
• Product Code: LJS
• UDI-Device Identifier: H96560M7011010
• UDI-Public: H96560M7011010
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2026

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 Model Number: 60M701101
• Device Lot Number: 5850674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 04/06/2026; 04/11/2026; 05/22/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 04/09/2026; 05/05/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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 Sex: Female