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Catalog Number H965700393031
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Not Applicable (3189)
Event Date 06/11/2018
Event Type  malfunction  
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 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.
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Type of DeviceMANIFOLD
Manufacturer (Section D)
10 glens falls technical park
glens falls NY 12801
Manufacturer (Section G)
10 glens falls technical park
glens falls NY 12801
Manufacturer Contact
law ryan
10 glens falls technical park
glens falls, NY 12801
MDR Report Key7677277
MDR Text Key114144119
Report Number1317056-2018-00128
Device Sequence Number1
Product Code DTZ
UDI-Device IdentifierH965700393031
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/11/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2021
Device Catalogue NumberH965700393031
Device Lot Number5324731
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial