MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO; BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY - 5F X 55CM DUAL LUMEN CATHETE

Model Number	45889
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A distributor reported that an end user experienced bioflo 5f double lumen hub cracks requiring removal of the device from the patient.The patient's bioflo picc had initially been placed in the right vena cephalic to been used for nutrition.Eleven days post placement, a crack was discovered in the distal end of the clavicle/hub.There was still reported to be good inflow and outflow in both runs and was not disconnected at this time.The end user placed tape over the device and used a sterile plug on the end of the hub.Three weeks later a crack/leak was also discovered on the other clavicle/hub.At this time the patient's picc was removed.
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).
Additional Manufacturer Narrative
Additional information: a2, a3a, a4.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of picc hub cracked 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.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 pasv valve luer hub while making a connection with the nc.Grasping the pasv valve hub while connecting a syringe/tubing set to the nc can transmit additional torque to the pasv 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).
Additional Manufacturer Narrative
Received one (1) 5f dl bioflo picc for evaluation.As received, the blue curos cap was still connected to both the purple/purple valve and white/purple valve.A "%" label was attached to the white/purple valve.The catheter was trimmed to approximately the 4cm mark.The cracks were not visible with the curos caps connected.While cleaning the device, fluid was flushed through both lumens and was escaping from between the curos caps and the valves.The removal of the curos cap on the white/purple valve was slightly difficult to remove.After removal, there was evidence of forceps marks on the white luer lock.A crack was observed on the white luer lock (cavity 1) of the white/purple valve.The removal of the curos cap on the purple/purple valve was not difficult to remove.After removal, a crack was observed on the purple luer (cavity 4) of the purple/purple valve.The customer's complaint description is confirmed for picc hub cracked (white/purple valve).No component manufacturing/molding non-conformances was observed during visual inspection of the returned sample.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 pasv valve luer hub while making a connection with the nc.Grasping the pasv valve hub while connecting a syringe/tubing set to the nc can transmit additional torque to the pasv female luer hub.Inadequate flushing of the device lumen may also be a contributing factor.Reference (b)(4).Corrections: d2a, d6b, e3, g1.

• Brand Name: BIOFLO
• Common Device Name: BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY - 5F X 55CM DUAL LUMEN CATHETE
• 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 ; 50 main street; suite 1000; white plains,, NY 10606 ; 8134543296
• MDR Report Key: 22166715
• Report Number: 1317056-2025-00149
• Device Sequence Number: 9218662
• Product Code: LJS
• UDI-Device Identifier: H965458890
• UDI-Public: H965458890
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/24/2025

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: 04/30/2025
• Device Model Number: 45889
• Device Lot Number: 5778060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 09/11/2025; 10/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/19/2025; 09/17/2025; 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 64 KG