MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; MANIFOLD

Catalog Number	H965700393031
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot (5324731) for item number h965700393031 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 may 2018 angiodynamics complaint report was reviewed for the manifolds product family and the failure mode "package - hole/perforated." no adverse trend was indicated.Based on examination of the device sample returned by the distributor, the complaint is confirmed for a hole in the mylar side of the pouch.Although we are unable to determine an exact root cause for the pouch damage, potential root causes for this incident include the bottom of the manifold handle core pressing outward against the mylar, this could be the result of improper shipping and handling after leaving angiodynamics facility.The pouches are 100% inspected per angiodynamics' procedure during the sealing process and the final box process.This is the only reported complaint for this failure mode in the past 15 months for the manifold product family.A review of the angiodynamics packaging configuration has been performed and has determined that the pouch size is appropriate for the pouch contents and the number of pouches per shipper box is also appropriate.The directions for use (dfu) supplied with the manifolds contains the warning: "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).
Event or Problem Description
As reported by angiodynamics' distributor in (b)(4), a manifold pouch was noted to have a hole in the mylar portion, thereby compromising the sterility.The device was not used on a patient, and has been returned to angiodynamics.

• Brand Name: ANGIODYNAMICS
• Common Device Name: MANIFOLD
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7677277
• Report Number: 1317056-2018-00128
• Device Sequence Number: 2580470
• Product Code: DTZ
• UDI-Device Identifier: H965700393031
• UDI-Public: H965700393031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K782095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: H965700393031
• Device Lot Number: 5324731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1