MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	45894
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer and an investigation into the root cause for event 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 distributor reported a customer complaint regarding a bio-stable 3f sl-55cm mst-70 kit valved with nitinol guidewire pg.One day following picc placement, when nurses injected water through the syringe connector, water was found to be leaking from the catheter line.There was no resistance when pushing water or medication through the device.Ultimately, the patient required removal and replacement of the device 6 days later.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
Received for evaluation was a 3f sl picc.As received, the picc was trimmed at the 20cm mark.Sample was flushed and no leaks were observed.The sample was submerged under water and flushed with air, and no air bubbles could be observed.Could not duplicate complaint.The customer's reported complaint description of picc/catheter tubing leaked was not confirmed during evaluation of the returned complaint sample.There was no damage or device non-conformance (e.G.Leak) observed during visual and functional testing.The customer's experience with this picc device could not be definitively determined.A review of the device history records was performed for the indicated lot 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: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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 ; 8007726446
• MDR Report Key: 22292870
• Report Number: 1317056-2025-00153
• Device Sequence Number: 12980684
• Product Code: LJS
• UDI-Device Identifier: H965458940
• UDI-Public: H965458940
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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: 01/31/2026
• Device Model Number: 45894
• Device Lot Number: 5841535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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 Age: 24 MO
• Patient Sex: Male