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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 Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 02/27/2017
Event Type  malfunction  
Manufacturer Narrative
The manufacturer is currently waiting for the arrival of the iv set.
 
Event Description
The user reported leakage of the iv set. No patient harm or injury occurred in this case.
 
Manufacturer Narrative
The user-reported leaking issue was not confirmed. Zyno medical performed testings on 10 unopened samples of returned iv set with the same lot number on 06/14/2017, and the investigation report is attached. (b)(4).
 
Event Description
This is a follow-up for the initially filed mdr (3006575795-2017-00070).
 
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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 Key6379119
MDR Text Key69115262
Report Number3006575795-2017-00070
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,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2-80072
Device Lot Number1604008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Yes
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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