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

Model Number	45833
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
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 ir-145 kit valved.It was reported the hub broke off a line that was already in use.The picc required removal and replacement.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 hub detached (broken from oversleeve bond joint) cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Potential root cause is handling damage (excessive force applied to hub-to-oversleeve junction) during device use.Labeling review: the dfu that is supplied in bioflo kits item number: (16600224-01) contains the following precaution: it is recommended that only luer lock accessories be used with the · bioflo¿ picc with endexo¿ and pasv¿ valve technology.Repeated over-tightening may reduce hub connector life.Do not use hemostats to secure or remove devices with luer lock hub connections.Flushing - recommended procedure: 1.Flush the catheter after every use, or at least every seven days when not in use, to maintain patency.Use a 10 ml syringe or larger.2.Flush the catheter with a minimum of 10 ml of sterile normal saline, using a "pulse" or "stop/start" technique.Warning: if using bacteriostatic saline, do not exceed 30 ml in a 24-hour period.3.Disconnect the syringe and attach a sterile end cap to each luer lock hub.Note: this is the recommended flush procedure for this catheter.If using a different procedure than listed above, the use of heparin may be necessary.Follow institutional protocol for catheter flushing.Precaution: incompatible drug delivery within the same lumen may cause precipitation.Ensure that the catheter lumen is flushed following each infusion.Precaution: if resistance is met when flushing, it is recommended that no further attempts be made.Further flushing may result in catheter rupture.Refer to institutional protocol for clearing occluded catheters.Precaution: place a cap on the hub after use to reduce the risk of contamination.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.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: 21026636
• Report Number: 1317056-2024-00270
• Device Sequence Number: 9106952
• Product Code: LJS
• UDI-Device Identifier: H965458330
• UDI-Public: H965458330
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2025

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: 05/31/2026
• Device Model Number: 45833
• Device Lot Number: 5824559
• 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: 12/06/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2024
• 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 Sex: Unknown