MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / ANGIOVAC; CATHETER, CANNULA & TUBING, CARDIOPULMONARY BYPASS

Catalog Number H965251850

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device from the reported event is expected to be returned to angiodynamics but has not yet arrived.Upon receipt of the device and completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Event Description

As reported end user hospital noted a small hole in the packaging of the angiovac cannula, thereby compromising the sterility.The device was not used on a patient.It will be returned to angiodynamics for evaluation.

Manufacturer Narrative

A review of the device history records was performed for the reported packaging lot for any deviations related to the reported defect of the complaint.The review confirms that the lot met all material, assembly and performance specifications.The angiodynamics complaint report was reviewed for the angiovac product family and the failure mode,"package - hole/perforated." no adverse trends were identified.As no sample was returned for evaluation, the exact root cause of the reported issue is unable to be determined.All pouches are 100% inspected per angiodynamics procedures during the sealing and final box processes.Employees involved in the packaging/final boxing of the reported lot of product have been made aware of this complaint.The directions for use (dfu) packaged with the angiovac contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged." ((b)(4)).

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6851211
• MDR Text Key: 85287384
• Report Number: 1317056-2017-00073
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251850
• UDI-Public: H965251850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: H965251850
• Device Lot Number: 4943462
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• 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