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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 B2-70071-DF
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Not Applicable (3189)
Event Date 12/29/2016
Event Type  malfunction  
Manufacturer Narrative
The failed iv set was not captured by the user, therefore not sent to the manufacturer for evaluation.
 
Event Description
The user reported an issue of tubing leaking after flushing the line. No patient was involved in the event.
 
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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 Contact
chaoyoung lee
177 pine street
natick, MA 01760
5086502008
MDR Report Key6282671
MDR Text Key66007563
Report Number3006575795-2017-00025
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 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70071-DF
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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