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

Model Number	45884
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	01/08/2020
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
As reported: bioflo pasv 6f tl - picc was placed (b)(6) 2020.Patient was sent for x-ray and the center valve had fallen off the hub within 10 minutes of being replaced.Patient was sent back to ir to get a new picc placed.Center valve used for cvp monitored detached, rn re-attached, but still replaced picc as a precaution.No patient injury or complications were reported.The reported defective disposable device has been returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Received 1 used 6f tl bioflo picc and 10 unopened/unused picc kits of reported lot for evaluation.As received, the one used 6f tl bioflo picc was returned with bio material/blood inside and out.The luers appeared to be firmly attached to each oversleeve.A firm tug test was performed by hand on the epoxy bond site of the hub and the oversleeve section of the returned bioflo picc sample.The connection between the three components remained attached.10 unused samples: no visual defects were noted.A firm tug test was performed by hand on the epoxy bond site of the hub and the oversleeve section of the returned unused 6f tl bioflo picc samples.The connection between the three components remained attached.The complaint description of detached valve from the oversleeve is confirmed.The adhesive was applied to the valve, but the valve was never fully inserted into the oversleeve at the time of manufacture; employee error during assembly.When the catheter is built, valves are preloaded into the oversleeve, adhesive is applied and then the valve is fully seated using a seating press.If the valve had been fully seated the adhesive would have been smeared in a thin layer.Employees were batching the preloading of valves, then applying glue and seating valves.This batching could lead to poor segregation between completed and partially completed product.Correction/corrective actions: the manufactuirng procedure for assembling this product is being changed to implement a single piece flow line.Thise change is designed to reduce assembly errors and improve segregation.All employees involved in the above issues were made aware of this complaint event.The root cause of this event was confirmed to be a manufacturing non-conformance associated with a reportable event.Labeling review: the dfu that is supplied in the reported kit (item number 14600128-01) 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 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 NY 12801
• MDR Report Key: 9617327
• Report Number: 1317056-2020-00012
• Device Sequence Number: 2721148
• Product Code: LJS
• UDI-Device Identifier: H965458840
• UDI-Public: H965458840
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2020

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: 09/30/2021
• Device Model Number: 45884
• Device Catalogue Number: H965458840
• Device Lot Number: 5537002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1