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

Catalog Number	75041
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	10/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported 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
A clinical nurse manager reported an issue with a bioflo picc (valved) 6ftl-55cm maximal barrier nursing kit w/70cm nitinol wire.A few days, post placement, the hub was found to be detached from the clear lumen.Treatment had been provided approximately 2.5 hours before the hub was noted to be detached.It was unknown if the picc had been flushed after the treatment was provided.The device was removed but not replaced as the patient no longer needs a picc.The patient did not experience any adverse effects, harm, or require medical intervention because of this incident.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 6f triple lumen bioflo picc.As received, the customer reported complaint event description is confirmed.The extension leg was detached at the extension tubing-to-oversleeve junction.Extension tubing detached at the junction with the tubing-to-oversleeve and the tubing failure is jagged, indicating a ripping tensile failure.Based on the jagged nature of the tubing failure the likely root cause is damage due to handling/use.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 the reported kit contains the following precaution and warnings: do not use if package is opened or damaged."it is recommended that only luer lock accessories be used with the bioflo midline catheter with endexo technology.Repeated over-tightening may reduce hub connector life.Do not use hemostats to secure or remove devices with luer lock hub connections.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: 12688118
• Report Number: 1317056-2021-00177
• Device Sequence Number: 4444385
• Product Code: LJS
• UDI-Device Identifier: H965750415
• UDI-Public: H965750415
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K131038
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2021

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: 12/31/2021
• Device Catalogue Number: 75041
• Device Lot Number: 5668351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2021
• 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 Age: 37 YR
• Patient Sex: Male