MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO PICC WITH ENDEXO TECHNOLOGY; BIOSTABLE PICC

Catalog Number	60M61072182
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
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 nurse reported an issue with a biostable picc from a tandem 5f dl bioflo picc kit.The picc was placed to provide access for moderate sedation, to be used during an electro-convulsive treatment (ect) a few weeks later.During preparation for the ect procedure, blood return was unable to be established with the tan lumen; however, flushing was able to be performed, without resistance.The other lumen (purple) is fully functional.Ultimately, the ect procedure was completed with this device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.After the procedure was completed, the nurse discovered that the tan lumen now had inability to be flushed with normal saline and blood return could not be established.The nurse applied a sticker tape to the tan lumen indicating it was not functional.  she also reported that after picc insertion, and prior to discharge from the hospital, the patient's husband was told by the behavioral nurse to flush the purple lumen only and not to flush the tan lumen at home.  no heparin was instilled while the patient was at home by home health agency and device was only flushed with normal saline at home.Ultimately the picc was removed due to this issue and replaced.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of aspiration difficulty and difficulty flushing cannot be confirmed.No picc sample was returned for evaluation.  without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.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.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.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 TECHNOLOGY
• Common Device Name: BIOSTABLE PICC
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15996019
• Report Number: 1317056-2022-00147
• Device Sequence Number: 5995744
• Product Code: LJS
• UDI-Device Identifier: H96560M610721821
• UDI-Public: H96560M610721821
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2022

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: 09/30/2022
• Device Catalogue Number: 60M61072182
• Device Lot Number: 5688001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 12/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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: Male