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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 A2-80070
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Not Applicable (3189)
Event Date 01/25/2013
Event Type  malfunction  
Manufacturer Narrative
The complaint could not be confirmed. The iv set was received in condition making evaluation impossible. The iv set was within the opened pouch and the spike cap was on top of the spike. The cap did not fall off when the drip chamber was turned upside down. It is possible that the nurse put the cap back on after finding it was loose. Possible reason for the reported issue is that not enough pressure was applied to secure the cap. 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 (3006575795-2016-00120_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 an issue with an iv set: "when opened had no cap on the spike". 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 Key6247848
MDR Text Key64735588
Report Number3006575795-2016-00120
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 Date03/01/2015
Device Model NumberA2-80070
Device Lot Number58157KS
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
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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