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Catalog Number H965640382001
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Not Applicable (3189)
Event Date 08/30/2016
Event Type  malfunction  
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 july 2016 complaint report was reviewed for the stopcock/manifold product family and the failure mode,"hole in pouch. " no adverse trends were identified. The returned sample was visually inspected and the hole in the pouch was confirmed. There was a (b)(4) label on the pouch with the hole. The root cause of the hole is the handle from the manifold presses outward against the tyvek. As part of the receiving process at (b)(4), all pouched products are removed from their inner boxes and a (b)(4) label (in (b)(4)) is applied to each pouch. Additional handling may occur if product is 100% visually inspected. The pouched product is then re-boxed into the inner box by the (b)(4) warehouse employees. The hole in the tyvek was likely caused by the handle of the manifold in the pouch, however, what caused the handle to be pushed against the tyvek in a manner that resulted in a hole cannot be determined. Potential contributing factors include: - handling of the pouches as they are placed in the inner boxes. - handling during transit to (b)(4) warehouse. - handling during (b)(4) labeling/inspection and re-boxing process. All pouches are 100% inspected per angiodynamics procedures during the sealing and final box processes. The kit packaging department has been made aware of this report and re-training has been conducted on the applicable packaging and inspection procedures. The directions for use (dfu) packaged with the kits contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process. Do not use if sterile barrier is damaged. " (b)(4).
Event Description
As reported by angiodynamics' distributor in (b)(6), in the distributor's warehouse a small hole was found in the tyvek portion of a manifold pouch, breaching the sterility. The device had not been provided to a hospital, and was returned to angiodynamics for evaluation.
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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 Key5966425
MDR Text Key55267881
Report Number1317056-2016-00142
Device Sequence Number1
Product Code DTZ
UDI-Device IdentifierH965640382001
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
Type of Report Initial
Report Date 09/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberH965640382001
Device Lot Number4963893
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial