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

Model Number	45881
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference pr25163.
Event or Problem Description
An angiodynamics territory manager(tm) reported an issue with a biostable picc w/pasv.It was reported that the picc is normally fixated with the statlock; however, due to the adhesive on the statlock, the picc required removal and replacement.There was no patient injury or harm due to this event.It was indicated the reported device is available for return to the manufaturer for a device evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.However, the customer supplied pictures of the reported defect.The statlock component is purchased by angiodynamics from the supplier bard access systems.The pictures have been sent to bard access systems for evaluation, root cause determination and corrective action.Scar004213 was sent to bard access systems for a device history records (dhr) review of supplier lot.Complaint file has been closed out due to three good faith effort attempts to the supplier, bard access systems for dhr review of supplier lot.The supplier was non-responsive.The reported complaint description was confirmed based on the photograph provided.However, a root cause for the defect could not be determined.The reported packaging lot (5589138) for item number (b)(4) had purchased component item number 17700006 (angiodynamics lot 677186 [sl# (b)(6)]) packaged in it.A review of the device history records was performed for the indicated packaging and component 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.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 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: 10562383
• Report Number: 1317056-2020-00149
• Device Sequence Number: 11419819
• Product Code: LJS
• UDI-Device Identifier: H965458810
• UDI-Public: H965458810
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K121089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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: 03/31/2022
• Device Model Number: 45881
• Device Catalogue Number: 45881
• Device Lot Number: 5589138
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1