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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYANMICS / PROTECTION STATION PLUS INTRAVENOUS ADMINISTRATION SET

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ANGIODYNAMICS ANGIODYANMICS / PROTECTION STATION PLUS INTRAVENOUS ADMINISTRATION SET Back to Search Results
Catalog Number H965640009351
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Not Applicable (3189)
Event Date 03/01/2016
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 (b)(6) 2016 complaint report was reviewed for the closed system 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. The hole was caused by the edge of the roller clamp assembly. There is an approx. 1/8" slice in the tyvek side of the pouch that aligns with the edge of the roller clamp. As part of the receiving process at (b)(4) ((b)(4)), all pouched products are removed from their inner boxes and a (b)(4) label ((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 edge of the roller clamp, however, what caused the roller clamp 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 directions for use (dfu) packaged with the kits contain the following warning: "contents supplied sterile using an (b)(4) process. Do not use if sterile barrier is damaged. " ((b)(4)).
 
Event Description
As reported by angiodynamics' distributor in (b)(4), in the distributor's warehouse a small hole was found in the tyvek portion of the closed fluid system pouch, breaching the sterility. The product had not been provided to a hospital and was returned to angiodynamics for evaluation.
 
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Brand NameANGIODYANMICS / PROTECTION STATION PLUS
Type of DeviceINTRAVENOUS ADMINISTRATION SET
Manufacturer (Section D)
ANGIODYNAMICS
10 glens falls technical park
glens falls NY 12801
Manufacturer (Section G)
ANGIODYNAMICS
10 glens falls technical park
glens falls NY 12801
Manufacturer Contact
law ryan
10 glens falls technical park
glens falls, NY 12801
5187424488
MDR Report Key5529865
MDR Text Key41666170
Report Number1317056-2016-00046
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K852140
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 03/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue NumberH965640009351
Device Lot Number4963977
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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