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

Model Number	45871
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that 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
An end user reported an issue with a bio-stable 5f dl-55cm mst-70 kit non-valved.Originally when the patient reported the broken clamp, the clamp was removed and a temporary clamp was applied.Then few days later patient called and reported that line was pulled back by 5 cm the temporary clamp caught her sweater and the line came out.An overwire was done and the line was exchanged for a single lumen picc on (b)(6) 2024.This patient has had multiple piccs over the years and does need long term access for tpn.She always has been very good with her lines.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
The customer's reported complaint description of picc catheter tubing was pulled out of the patient's arm when removing a sweater could not be confirmed given the patient centric nature of this event.The white clamp was previously reported as being broken (reference (b)(4)) and a temporary clamp but in place.There were no other reported complaints of picc malfunction or performance issue, therefore, the picc device was not returned for evaluation.A device history records review of the packaging/assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.In addition, there have been no other reported complaints against the indicated packaging/assembly lots (or any other lot) for similar patient user error of pulling catheter tubing out of their arm for the bioflo picc product family in the past 15 months, as such, this is deemed to be an isolated incident.Labeling review: the directions for use (dfu) provided with the picc device contains the following statements: intended use/indications for use: the bioflo picc with endexo 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, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media.Precaution: patients must be educated regarding the care and maintenance of their picc.The healthcare provider is responsible for this patient instruction.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 ; 5086587990
• MDR Report Key: 21026633
• Report Number: 1317056-2024-00303
• Device Sequence Number: 9106951
• Product Code: LJS
• UDI-Device Identifier: H965458710
• UDI-Public: H965458710
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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
• Device Expiration Date: 08/31/2025
• Device Model Number: 45871
• Device Lot Number: 5798824
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2023
• 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