MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H965600200211
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The end user hospital has indicated that the sample will be returned for evaluation, but it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not yet returned to manufacturer.
Event or Problem Description
End user hospital reported receiving an angiographic convenience kit with a hole in the packaging, thereby breaching the sterility.The kit was not used and will be returned to angiodyanmics for evaluation.
Additional 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 march 2016 angiodynamics complaint report was reviewed for the convenience kit product family and the failure mode "pouch torn/holes {sterile}." no adverse trend was identified.As received, the complaint is confirmed for a hole in the tyvek side of the pouch.The most likely root cause for this incident is handling after the package left the angiodynamics facility.The pouches are 100% inspected per angiodynamics' procedure during the sealing process and this is an obvious defect that would have been detected.A review of the angiodynamics kit packaging configuration was performed for the reported kit by documentation compliance and it was determined that the pouch size is appropriate for the pouch contents and the number of kits per shipper box is also appropriate.Packaging employees are being made aware of the complaint in order to improve their awareness of the defect and to improve the probability of identifying the defect in the future.The directions for use supplier to the end user with the convenience kit contains this statement: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.If damage is found, call your angiodynamics representative.Inspect prior to use to verify that no damage has occurred during shipping." (b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5617231
• Report Number: 1317056-2016-00060
• Device Sequence Number: 306592
• Product Code: OEZ
• UDI-Device Identifier: H965600200211
• UDI-Public: H965600200211
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2016

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: 02/28/2019
• Device Catalogue Number: H965600200211
• Device Lot Number: 4999894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2016
• Supplement Report FDA Received Date: 06/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1