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

Model Number	45881
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
An angiodynamcis tm reported and end user experienced an issue with a bioflo picc with pasv.The picc was advanced over the 145cm guidewire to place the picc.When withdrawing the guidewire, there was a continuous bleed back of blood.The amount of blood loss was reported to be approximately <10ml.The blood flow was stopped be reinserting the guidewire.The guidewire and picc were removed as one unit.A new of the same picc was placed.There was no serious harm or injury to the patient due to this event.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.
Additional Manufacturer Narrative
Returned for evaluation was one single lumen bioflo picc.As received, the catheter was returned trimmed at the 31cm mark and appeared used.The valve was visualized microscopically.The slit in the gasket of the valve was closed and centered.No cracks were noted to the purple hub.There were no kinks, compressions or other damage noted to the returned catheter.During the disinfection process, the catheter was able to be flushed.A guidewire {145cm} was inserted and was able to pass freely through the valve.The following infusion and aspiration pressures were verified on the pasv valve using a water column and a ruler: infusion pressure: sample met specification of 30-60 cmh2o.Aspiration pressure: sample met specification of 200-300 cm h2o.The customer's complaint description of bleed back from the valve could not be confirmed during sample review.Proper valve functionality was confirmed, and infusion/aspiration pressures met specification.No manufacturing non-conformances were observed during sample evaluation.A root cause for the reported event cannot be established.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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.(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: 11182951
• Report Number: 1317056-2021-00009
• Device Sequence Number: 3795153
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 45881
• Device Catalogue Number: 45881
• Device Lot Number: 5628804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 02/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 65