MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	60M701102
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that the patient has had four episodes of blood backing up into both lumens of their 5f dl bioflo picc with pasv.These episodes occurred not in relation to hydration infusion, but were noted when patient lifted their arms to change clothing.There was no damaged noted to the picc, the needless connector was tight and the patient avoided bottoming out ns flush syringes when flushing the device.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.The patient had declined removal and replacement of the catheter due to poor venous access.The frequency of use was 4 days weekly at the patient's home and in the hospital.The catheter was flushed after use with saline and was being used for iv hydration.It was later reported that on (b)(6) 2023, due to withdrawal occlusion both lumens (cathflo instillation ineffective), the picc was removed and replaced.
Additional Manufacturer Narrative
Returned for evaluation was one 5f dl bioflo picc.As received, a flat spot was noted at the 10cm mark.No other visual defects were noted to the returned sample.The valves were visualized under a microscope.The purple/purple valve was normal in appearance.The purple/white valve appear to have the edges of the slit in the disc slightly overlapping.White/purple valve: during initial testing of the valve, the valve did not hold water.This was due to the valve overlapping as noted.The valve was exercised with air to re-seat the valve using a 10 ml syringe and then testing was repeated with the following results: infusion pressure: sample met specification of 30 - 60 cmh2o.Aspiration pressure: sample met specification of 200 - 300 cmh2o.After exercising the valve, the purple/white valve was re-seated and met infusion/aspiration pressure specifications.The purple/purple valve also met infusion/aspiration pressure specifications.The customer's reported complaint description of of blood backing up into lumen was confirmed for the white/purple valve but not confirmed for the purple/purple valve.The root cause for the white/purple was determined to be the intermittent overlapping of the disc slit edges.A definitive root cause for the valve overlapping could not be determined, however, this appears to be an intermittent issue.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.Labeling review: the dfu that is supplied in bioflo kits 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.Warn ing: 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).

• Brand Name: BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: 16715867
• Report Number: 1317056-2023-00044
• Device Sequence Number: 15269973
• Product Code: LJS
• UDI-Device Identifier: H96560M7011021
• UDI-Public: H96560M7011021
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 10/31/2023
• Device Catalogue Number: 60M701102
• Device Lot Number: 5707928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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