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Catalog Number H965914004001
Device Problem Unsealed Device Packaging (1444)
Patient Problem Not Applicable (3189)
Event Date 10/05/2018
Event Type  malfunction  
Manufacturer Narrative
A review of the device history records was performed for the reported packaging lot for item number h965914004001 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 recent angiodynamics complaint report was reviewed for the y-adaptor product family and the failure mode "seal compromised". No adverse trend was indicated. Based on the sample supplied from the customer, the customer's complaint for "improper seal (seal compromised) is confirmed. The tip of the introducer sheath protector was sealed in the closure seal area of the pouch causing the seal to become compromised. The root cause is that responsible employees did not seal the pouch correctly and properly visualize per angiodynamics' procedures. Packages are 100% visualized for this type of non-conformance and the employees who packaged the lot in question did not identify the non-conforming units during their inspection. In an effort to heighten awareness of the performance of our products in the field, recent complaints have been reviewed in a weekly meeting with the entire department. All employees associated with the issue have been retrained on the applicable packaging and inspection procedures. ((b)(4)).
Event Description
As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a compromised pouch seal was found on a guidewire introducer pouch, thereby breaching sterility. The pouch 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 Key8032170
MDR Text Key125910169
Report Number1317056-2018-00186
Device Sequence Number1
Product Code LIT
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 11/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/31/2021
Device Catalogue NumberH965914004001
Device Lot Number5373017
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown