MAUDE Adverse Event Report: ANGIODYNAMICS BIOSTABLE PICC WITH PASV; PERIPHERALLY INSERTED CENTRAL CATHETER,

Model Number	45811
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
Picc - vacutainer broke off in the hub - user had to re-insert another picc for a patient who had a blood sample taken via the picc when the end of the vacutainer broke off the hub.The picc was removed and replaced with a new of the same device.There was no patient harm or injury due to this event.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a dual lumen bioflo picc.As received, the customers complaint description is confirmed for vacutainer broke off in hub.There is a piece of plastic inside the hub of the valve.The complaint description is confirmed for vacutainer broke off in the hub.Although the complaint description is confirmed, a definitive root cause for the event cannot be determined.This does not appear to be a manufacturing defect.A possible root cause may be the end user used excess force when the vacutainer was inserted in the valve causing the tip to detach inside the valve.A review of the device history records was performed for the indicated packaging and assembly lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.Labeling review: the dfu item number states: 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.Blood sampling recommended procedure.1.Stop administration of infusates.2.Using aseptic technique, swab catheter hub and allow to air dry.3.Flush the selected lumen with 10 ml of sterile normal saline.4.Using the same syringe, aspirate a small amount of blood and fluid (3-5 ml minimum) by slowly pulling and holding the plunger, allowing the pasv valve to open.Discard syringe according to institutional protocol.5.Using a second 10 ml syringe or collection set, slowly withdraw specimen.6.Flush the catheter using a "stop/start" or "pulse" technique with a minimum of 20 ml of sterile normal saline immediately following withdrawal of a blood sample.Use a 10 ml or larger syringe.7.Attach a sterile end cap to the luer lock hub.8.Transfer specimens per institutional protocol.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint # (b)(4).

• Brand Name: BIOSTABLE PICC WITH PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• MDR Report Key: 9699587
• Report Number: 1317056-2020-00016
• Device Sequence Number: 13880318
• Product Code: LJS
• UDI-Device Identifier: H965458110
• UDI-Public: H965458110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2020

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: 05/31/2021
• Device Model Number: 45811
• Device Catalogue Number: H965458110
• Device Lot Number: 5474530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1