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

Model Number	45889
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received for evaluation was one bioflo picc w/ pasv.As received, the needleless connectors were still connected to the purple/purple valve and white/purple valve.The crack was visible in the purple luer lock (cavity 1) of the purple/purple valve prior to removing the needleless connector.The removal of the needleless connector on the purple/purple valve was slightly difficult to remove.After removal, there was evidence of forceps marks on the purple luer lock.The needleless connector was unable to be removed from the white/purple valve.There is evidence of forceps marks around the circumference of the white luer lock.The customer's complaint description is confirmed for picc hub cracked (purple/purple valve).No component manufacturing/molding non-conformances was observed during visual inspection of the returned sample.Forcep marks were observed on the white luer.The most likely root cause for the cracked female valve housing is due to an over tightened connection with a mating male luer (likely a needleless connector).A contributing factor to the over-tightened connection may be the mechanics/hand placement during infusion access.It is preferable to grasp the needleless connector (nc) when connecting a syringe/tubing to it rather than grasping the luer hub while making a connection with the nc.Grasping the luer hub while connecting a syringe/tubing set to the nc can transmit additional torque to the female luer hub.Inadequate flushing of the device lumen may also be a contributing factor.A dhr review of the packaging/assembly/valve lots were reviewed for any deviations related to the reported hub crack failure mode.The review confirms that the lots met all material, assembly and performance specifications with no internal non-conformance reports (ncr) written.Angiodynamics has created an instructional video regarding the care and maintenance of the bioflo picc; reference youtube video, "angiodynamics bioflo picc care and maintenance instructional video" uploaded on november 18, 2020.This video is intended as a visual representation of information provided in the dfu for clinicians who are responsible for the care and maintenance of piccs but are not responsible for picc placement.Labeling review: the dfu that is supplied with the bioflo picc device contains the following statements: 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 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).
Event or Problem Description
A distributor reported an end user experienced an issue when using a bio-stable 5f dl 55cm mst-70 kit valved, with nitinol guidewire pg.It was reported that there was a fracture of one lumen near the fitting of the power picc.It occurred on the surgical ward, (b)(6) 2025 and was noted during a dressing change.The picc had been inserted via ii cnc cannulation, not by icu, and for the purpose of tpn.The picc was removed and it is unknown if it was replaced.

• 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: 22166700
• Report Number: 1317056-2025-00148
• Device Sequence Number: 7789363
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2025

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: 45889
• Device Lot Number: 5824274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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