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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 Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Not Applicable (3189)
Event Date 12/29/2014
Event Type  malfunction  
Manufacturer Narrative
User reported issue was confirmed. Notification was sent to the supplier ((b)(4)) on 01/29/2015. (b)(4).
 
Event Description
The user reported that there was a hole in the primary iv set. The user stated that " some sets in this lot are crimped and it appears that is causing the hole in the one set. The sets were quite twisted in the packaging. " 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 Key6247569
MDR Text Key64736902
Report Number3006575795-2016-00125
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 01/12/2017
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 Date02/01/2017
Device Model NumberA2-80072
Device Lot Number14025403
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
Date Device Manufactured02/01/2014
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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