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

Catalog Number	60M1303115
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	09/30/2022
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
One day post placement of a rs tandem 5f dl bioflo picc , with the patient having already received a treatment via the picc, it was found to be missing the white connector on the double lumen.The line was immediately removed, and a bard picc was placed.The patient was discharged after 2nd chemo treatment via the bard picc, and the oncologist will monitor for infection.There was no report of the patient experiencing any adverse effects, harm, or require medical intervention as a result of this incident.
Additional Manufacturer Narrative
Returned for evaluation was one (1) 5f bioflo picc.In addition, the customer returned 9 unopened/unused shippers (4 kits per shipper; n=36 picc kits) of reported lot {5747692}.As received, the customer's complaint description was confirmed for white luer detached for the used picc sample returned.The white luer was not returned with the bioflo picc for evaluation.The purple luer was fully seated into the oversleeve.All 36 picc kits were opened and 10 out of the 36 were confirmed to have both luers unseated (luer barbs partially inserted into oversleeve); the remaining 26 had luers fully seated and bonded inside the oversleeve.The customer's reported complaint description of luers were unseated was confirmed via evaluation of the returned unopened picc kits.Ten (10) out of the 36 kits returned were observed to have both luers not fully seated into oversleeve.Based on manufacturing investigation, it was observed that the picc assemblies are grouped/bundled into a quantity of n=25.It is believed this product non-conformance was isolated to one (1) bundle of n=25 picc assembly devices that was issued to packaging job (b)(4) (total completed quantity of n=84).All 84 picc kits are believed to have either been opened/consumed by the end user customer or returned to angiodynamics as part of the complaint file investigations.The root cause of this event was confirmed to be a manufacturing non-conformance associated with epoxy bonding of the hub luer-to-oversleeve.The manufacturing luer assembly process procedure was reviewed.Root cause of this bundle of n=25 not having luers assembled correctly is operators not following bonding procedure instructions, i.E.Only one-color valve/luer is to be processed at a workstation at a time (not both at the same time) using the correct picc color tool.Dhr review of the packaging and assembly lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Correction/corrective actions: operators performing the valve bonding sequence for the picc assembly lot 5744028 have been re-trained on proper assembly procedure.In addition, a quality team meeting determined a process improvement to address correctly bonded luers.The manufacturing procedure was updated to add instructions for dual and triple lumen catheters so that each catheter has all luers/valves bonded at one time.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: 15638254
• Report Number: 1317056-2022-00125
• Device Sequence Number: 6518710
• Product Code: LJS
• UDI-Device Identifier: H96560M13031151
• UDI-Public: H96560M13031151
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2022

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: 09/30/2023
• Device Catalogue Number: 60M1303115
• Device Lot Number: 5747692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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