MAUDE Adverse Event Report: ANGIODYNAMICS BI; PERIPHERALLY INSERTED CENTRAL CATHETER,

Model Number	45891
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
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
A distributor reported an issue with a bio-stable 4f sl 55cm mst-70 kit valved with nitinol guidewire pg.Post procedure, it was noted the valve was not functioning as intended and producing bleed back.The device was removed from the patient.It was not indicated nor reported that the picc was replaced.There was no report of patient harm or adverse event by the end user.
Additional Manufacturer Narrative
This report is being submitted in order to close out the complaint record.The reported event was incorrectly reported, and does not meet the criteria of an adverse event based on new information provided.Reference (b)(4).
Event or Problem Description
New information provided reported the event occurred during initial placement of the device.Therefore, no medical intervention was required.This event does not meet the criteria of a reportable adverse event.This report is being submitteed in order to close out the complaint record.

• Brand Name: BI
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• 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: 13145890
• Report Number: 1317056-2022-00001
• Device Sequence Number: 11158186
• Product Code: LJS
• UDI-Device Identifier: H965458910
• UDI-Public: H965458910
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2022

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: 06/30/2023
• Device Model Number: 45891
• Device Catalogue Number: 45891
• Device Lot Number: 5689026
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/03/2022
• Supplement Report FDA Received Date: 01/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2021
• 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