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

Model Number	45889
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	07/09/2025
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 territory manager reported an end user experienced an issue when using a bio-stable 5f dl 55cm mst-70 kit valved with nitinol guidewire.On (b)(6) 2025, the nurse on duty noted that the patient picc line was leaking on the tubing.Immediately the nurse stopped the tpn which was running and notified the on call house officer.On call house officer reviewed and advised to stop using picc line.Team and cardiovascular nurse reviewed on (b)(6) 2025 and flushed with saline and confirmed the picc was leaking outside the patient.It was advised to remove the picc line and it was removed on (b)(6) 2025 by the nurse.The picc was replaced the following day.
Additional Manufacturer Narrative
Corrections: d2a, e1, e2, e3, g1.The customer's complaint description of picc line was leaking on the tubing [extension leg] was not confirmed since no product was returned for evaluation.Without receiving product for evaluation a root cause for this event cannot be determined.Handling damage to the picc extension leg tubing during device use (i.E.Damage from scissors during changing of dressing) is potential root cause for extension leg fracture/leak event.Device history review of the packaging/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 extension leg fractured issue.Labeling review: directions for use (dfu) that is supplied with this device contains the following statements: warnings: do not use if package is opened or damaged.Do not fully insert catheter up to suture wing.Do not use sharp objects to open package as damage to the device may occur.If catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair: in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.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).
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).
Additional Manufacturer Narrative
The customer's complaint description of picc line was leaking on the tubing [extension leg] was not confirmed based on evaluation of the returned complaint sample.The leak failure location was confirmed to be on the catheter tubing near the 2cm mark; hole in the catheter tubing.The hole was created by slice damage from a sharp object like scalpel or scissors; not a kink or burst failure mode.Picc was in situ for 82 days so slice damage is not related to picc manufacturing or during the implant procedure.Slice damage likely occurred during dressing change, i.E.Damage to catheter tubing from scissors.Device history review of the packaging/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 extension leg fractured issue.Labeling review: directions for use (dfu) that is supplied with this device contains the following statements: warnings: · do not use if package is opened or damaged.· do not fully insert catheter up to suture wing.· do not use sharp objects to open package as damage to the device may occur.· if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.· do not use sharp instruments near the extension tubes or catheter shaft.Precaution: do not use sharp objects to open package.Catheter repair in the event that the catheter is accidentally torn or broken, it is recommended that the catheter be replaced.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 AND PASV VALVE 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: ashleigh garcia ; 10 glens falls technical park; suite 1000; glens falls, NY 12801 ; 8134543296
• MDR Report Key: 22700995
• Report Number: 1317056-2025-00199
• Device Sequence Number: 15740697
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/21/2025

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 Model Number: 45889
• Device Lot Number: 5836687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 11/05/2025; 12/15/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 11/03/2025; 11/18/2025; 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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: 73 YR
• Patient Sex: Male