MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO; BIOFLO PICC WITH ENDEXO TECHNOLOGY

Model Number	45895
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A spectrum distributor reported an end user experienced an issue when using a bioflo 5f dl-55cm mst-70 kit non-valved with nitinol guidewire brazil.It was reported that there was difficulty extravasating contrast from the catheter possible due to improper positioning.Due to this issue, the picc was removed and replaced.There is no report of patient harm, or adverse event.
Additional Manufacturer Narrative
The reported device is not available 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.(b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of leak in the catheter tubing was not confirmed since no picc complaint sample was returned.Without receiving product for evaluation a definitive root cause cannot be determined.The picc was in situ for 6 days prior to the leak issue being observed, therefore, a manufacturing device non-conformance (i.E.Hole in the catheter tubing) is likely not the root cause since this would have been observed during the picc placement procedure.Review of the x-ray image provided shows contrast leak "lighting up" near the proximal end of the picc device, i.E.Suture wing-catheter tubing junction and the catheter tubing insertion point into the patient's vasculature.Potential root cause for this type of catheter leak failure mode post implant procedure/in situ is slice damage to the catheter tubing from a sharp object like scalpel or scissors.Slice damage may occur during dressing change, i.E.Damage to catheter tubing from scissors.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 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.Reference(b)(4).

• Brand Name: BIOFLO
• Common Device Name: BIOFLO PICC WITH ENDEXO TECHNOLOGY
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752
• MDR Report Key: 24505714
• Report Number: 1319211-2026-00046
• Device Sequence Number: 21322213
• Product Code: LJS
• UDI-Device Identifier: H965458950
• UDI-Public: H965458950
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 45895
• Device Lot Number: 5851041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 95 KG