MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ANGIOVAC; CATHETER, CANNULA & TUBING, VASCULAR

Catalog Number VTX-3022

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

Prior to the procedure, it was noted that the packaging of the angiovac cannula was torn, thereby compromising the sterility of the device.The device was not used and there was no patient impact.

Manufacturer Narrative

The packaging from the reported event is being returned to angiodynamics, but has not yet been received.Upon receipt of the sample it will be forwarded to our supplier, std med inc.Along with a supplier corrective action request (scar).A supplemental medwatch will be submitted upon completion of the investigation.

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot (106711-2) for item number vtx-3022 for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The angiodynamics complaint report was reviewed for the angiovac product family for the failure mode "tear in pouch.": no adverse trend was identified.As received, the returned product pouch had a tear in it as stated by the complaint reporter.A supplier corrective action request (scar) and the returned sample were sent to the supplier, duke empirical, for evaluation, root cause determination, corrective action and dhr review of supplier lot.Duke empirical indicated that the dhr review revealed no abnormalities that would contribute to this non-conformance.A definitive root cause and the origin of the torn pouch cannot be determined.However, the torn mylar is most likely a result of transit and/or handling damage that occurred at some point between the supplier (duke), the distributor (std) and the end user hospital.The directions for use provided with this device contains the following statement: "warning: do not use if product or sterile packaging is damaged." (b)(4).

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR
• Manufacturer (Section D): ANGIODYNAMICS, INC.; marlborough MA
• Manufacturer (Section G): ANGIODYNAMICS; 26 forest street; marlborough MA 01752
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 4231863
• MDR Text Key: 5002838
• Report Number: 2952363-2014-00010
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091304
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: VTX-3022
• Device Lot Number: 106711-2
• Other Device ID Number: ANGIOVAC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1