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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 A2-80071-DF
Device Problems Device Operates Differently Than Expected (2913); Physical Property Issue (3008)
Patient Problem Not Applicable (3189)
Event Date 12/19/2016
Event Type  malfunction  
Manufacturer Narrative
The failed iv sets have been sent to the contract supplier for evaluation on 01/03/2017. The manufacturer is still waiting for the results. A quality alert has been sent to the contract supplier to address the issue proactively on 01/03/2017.
 
Event Description
The user reported iv sets leaking at the air vent. The users had been opening the vent, when it was not necessary, while priming the line with standard iv bags, not bottles. Then they were unable to close the vent back up tightly, and the air vent does not close tightly. The sets were primed with chemo, taxol. No patient was involved, only the pharmacist was involved when priming.
 
Manufacturer Narrative
Zyno medical received the investigation report from the contract supplier on 06/05/2017. The user-reported leaking issue is confirmed. Corrective actions have been taken to address the manufacturing deficiency identified.
 
Event Description
This is a follow-up for the initially filed mdr (3006575795-2017-00004).
 
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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 Key6244078
MDR Text Key64593928
Report Number3006575795-2017-00004
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 06/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2-80071-DF
Device Lot Number1410004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
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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