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

Model Number	45813
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	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, the customer supplied a picture of the valve detached from the picc line.It cannot be determined from the picture if there is a sufficient amount of epoxy placed on the valve barbs.The customer's reported complaint description is confirmed via picture provided, however, 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.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).
Event or Problem Description
An end user reported an issue with a bio-stable 4f sl 55cm ir-145 kit.2 days post procedure, the purple hub detached.The picc was removed shortly afterward, and was not replaced.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.The reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Correction to section g3.Aware date ammended from 08/10/2021 to 08/02/2021.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: 12330307
• Report Number: 1317056-2021-00147
• Device Sequence Number: 2825500
• Product Code: LJS
• UDI-Device Identifier: H965458130
• UDI-Public: H965458130
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 03/31/2023
• Device Model Number: 45813
• Device Catalogue Number: 45813
• Device Lot Number: 5674827
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1