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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 B2-70072
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Not Applicable (3189)
Event Date 10/30/2012
Event Type  malfunction  
Manufacturer Narrative
The user-reported leaking issue was confirmed. Leakage was observed at the air vent on the drip chamber. The nonconforming product was sent to the supplier for failure analysis. 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 (b)(6) 2016. Zyno medical submitted an e-mdr (3006575795-2016-00109_complaint (b)(4)) on 10/26/2016 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 that "i popped the vent open, primed the tubing with d5 and hung a bottle of ivig. I noticed that ivig was dripping out of the vent hole at a pretty fast rate". Also, "while priming the tubing with the vent open, the d5 solution began leaking out of the vent. " no patient 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 Key6247792
MDR Text Key64736180
Report Number3006575795-2016-00109
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 01/13/2017
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 Date07/01/2014
Device Model NumberB2-70072
Device Lot Number1107026
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2012
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2012
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
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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