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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 H965700550091
Device Problems Hole In Material (1293); Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/09/2014
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 three stopcock pouches, breaching the sterility.The stopcocks were in a box of 50.The entire box was returned to navilyst medical by the warehouse.
 
Manufacturer Narrative
The devices which were the subjects of the complaint have been returned to navilyst medical for eval.Upon completion of the investigation into this incident, a supplemental medwatch will be submitted.(b)(4).
 
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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 Key4001531
MDR Text Key4774340
Report Number1317056-2014-00042
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K842829
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 06/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2017
Device Catalogue NumberH965700550091
Device Lot Number4722786
Other Device ID NumberSTOPCOCK
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/16/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received06/10/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/01/2014
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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