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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK

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NAVILYST MEDICAL NAVILYST MEDICAL; STOPCOCK Back to Search Results
Catalog Number H965700350031
Device Problems Hole In Material (1293); Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2014
Event Type  malfunction  
Event Description
As reported by navilyst medical's distributor in (b)(6), in the distributor's warehouse, a small hole was found in the tyvek portion of the stopcock pouch, breaching the sterility.The stopcock was one in a box of 50.The entire box was returned to navilyst medical by the warehouse.
 
Manufacturer Narrative
A review of the dhr 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 navilyst medical (b)(6) 2014 complaint report was reviewed for product family of stopcocks/manifolds 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.As part of the receiving process at nipro (the distributor in (b)(6)), all pouched products are removed from their inner boxes and a nipro label (in (b)(6)) is applied to each pouch.Additional handling may occur if the pouches are 100% visually inspected.The pouched product is then re-boxed into the inner box by the nipro warehouse employees.The hole in the tyvek was likely caused by the handle of the stopcock, 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: over-crowding of filled pouches in the in-process bins or improper handling of pouches as they are placed in inner boxes at navilyst medical.Handling during transit to the nipro warehouse.Handling at nipro during the labeling/inspection and re-boxing process.All pouches are 100% inspected per navilyst medical procedures during the sealing and the final box processes.The directions for use (dfu) for the stopcocks contain the following warning: "contents supplied sterile using an ethylene oxide (eo) process.Do not use if sterile barrier is damaged.
 
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Brand Name
NAVILYST MEDICAL
Type of Device
STOPCOCK
Manufacturer (Section D)
NAVILYST MEDICAL
glens falls NY 12801
Manufacturer (Section G)
NAVILYST MEDICAL
10 glens falls technical park
glens falls NY 12801
Manufacturer Contact
michael duerr
10 glens falls technical park
glens falls, NY 12801
5187424571
MDR Report Key4417452
MDR Text Key5376675
Report Number1317056-2015-00001
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K782095
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/09/2014
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
Device Operator Health Professional
Device Expiration Date09/30/2014
Device Catalogue NumberH965700350031
Device Lot Number4807038
Other Device ID NumberSTOPCOCK
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/22/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/09/2014
Initial Date FDA Received01/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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