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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET

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ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP IV ADMINISTRATION SET Back to Search Results
Model Number A2-80072
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Not Applicable (3189)
Event Date 05/13/2015
Event Type  malfunction  
Manufacturer Narrative
A) the user-reported issue was confirmed. The contract supplier performed the investigation. Root cause was determined as an issue in the molding injection and assembling process. Corrective action was taken to address this problem. B) the complaint was determined as not mdr reportable at the initial determination by following company procedures. This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on 08/11/2016. C) zyno medical submitted an e-mdr (3006575795-2016-00138_complaint (b)(4)) on 10/27/2016 through the fda's website and received the receipt. But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements. This is a re-submission regarding the same event.
 
Event Description
The customer reported leaking below the upper y-site of the iv set. No patient injury or harm was involved in this case.
 
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Brand NameZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
Type of DeviceIV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL LLC
177 pine street
natick MA 01760
Manufacturer (Section G)
ZYNO MEDICAL, LLC
177 pine street
natick MA 01760
Manufacturer Contact
chaoyoung lee
177 pine street
natick, MA 01760
5086502008
MDR Report Key6247652
MDR Text Key64736973
Report Number3006575795-2016-00138
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 01/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/01/2017
Device Model NumberA2-80072
Device Lot Number1408014
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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