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

Model Number	45891
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	07/07/2021
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
A distributor reported an issue with a bio-stable 4f sl 55cm mst-70 kit valved with nitinol guidewire.The following was reported: on (b)(6) 2021 the picc was successfully placed.Later that same day, the patient received cxr to confirm the tip location.It was noted the picc tip had crossed to the left subclavian by approximately 7cm.The picc was pulled back by 7.5cm and it was determined it was okay to continue using.On (b)(6) 2021, during ivc (r) hand, the picc site was dressed with crepe bandage.It was noted strike through bleeding.The medical personnel covered the site and was not concerned.The picc was able to be accessed still.Ivabx was administered as charted.It was also noted the patient's left foot was showing oedema, redness.The patient stated it was not causing any pain or issues.On (b)(6) 2021, the patient reported to nurse that he was bleeding.The nurse reported: "i looked at the picc, noticed the bung had been removed and it was bleeding.I put a bung on the picc and cleaned the patient up".The nurse informed their team leader and medical team and the picc was removed later that same day (b)(6) as per the medical team's instruction.The picc was discarded following removal.The picc was not replaced with a new one as the patient refused.The patient was discharged (b)(6) 2021.There was no report of permanent patient harm or injury due to this event.The reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's complaint description pasv valve bleed back could not be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The device history records for the bioflo pasv picc packaging and picc assembly lots were reviewed for any deviations related to the reported leaked 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: 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 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 NY 12801
• MDR Report Key: 12392007
• Report Number: 1317056-2021-00160
• Device Sequence Number: 20105664
• Product Code: LJS
• UDI-Device Identifier: H965458910
• UDI-Public: H965458910
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2021

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: 12/31/2022
• Device Model Number: 45891
• Device Catalogue Number: 45891
• Device Lot Number: 5658533
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR