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

Model Number	45872
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/15/2024
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 that an end-user experienced an issue with a bio-stable 5f dl-55 cm ir-145 kit non-valved picc.48 hours post placement, a leak was observed at the insertion site when infusing medication and fluids.The patient's left cubital fossa where picc was located was observed to swollen.The catheter was removed and replaced due to reduced flow rate at both lumens and worsening swelling.
Additional Manufacturer Narrative
Received one bioflo picc for evaluation.As received, the clamps were closed on the catheter's clear tubing, which were opened before testing.A visual inspection of the hubs and catheter shaft were reviewed using a microscope, no cracks or cuts/holes were noted.(catheter was 55cm noted to have not been trimmed) functional check: before air testing the clamps were opened to allow air to flow through the entire catheter.The catheter's tip was clamped off, the catheter was fully submerged into a beaker of water.A syringe with air was pressurized into the catheter to see if any air would leak for both lumens.There were no manufacturing non-conformances or damage observed during picc evaluation.The customer's experience with this picc device could not be definitively determined.The customer's reported complaint description cannot be confirmed.There was no damage or device non-conformance observed during evaluation of the returned sample.Dhr review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The device history records for the bioflo picc packaging, picc assembly, valve assembly and luer hub molding lots were reviewed for any deviations related to the reported failure mode.The review confirms that the lots met all material, assembly and performance specifications with no internal non conformance reports (ncr) written.Labeling review: as noted during the review of the directions for use (dfu) item number 16600226-01 that is supplied in the reported kit, the following precautions/warnings are stated: 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.Potential complications/adverse events catheter rupture management of lumen occlusion: provided there is no resistance with aspiration, flush the catheter vigorously with sterile normal saline to try to move the tip away from the vessel wall.Use a 10 ml or larger syringe.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis.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: 20901555
• Report Number: 1317056-2024-00236
• Device Sequence Number: 13013148
• Product Code: LJS
• UDI-Device Identifier: H965458720
• UDI-Public: H965458720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 02/28/2026
• Device Model Number: 45872
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: 82 YR
• Patient Sex: Male