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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-D
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Not Applicable (3189)
Event Date 05/29/2015
Event Type  malfunction  
Manufacturer Narrative
The user-reported issue was confirmed. A supplier corrective action request (scar (b)(4)) had been issued to address this issue. Root case was identified by the supplier that, during the bonding process of drip chamber to their components yielded an anomaly of "white fog". Operators did not identify this as a potential problem and proceeded to process entire lot with this anomaly. After the bonding process a leakage test performed and no leaks detected at that time. Mainly it is described as uneven adhesive coverage causing " white fog. " corrective action and preventive action (capa#(b)(4)) was taken by the supplier ((b)(4)) to address this issue. (b)(4).
 
Event Description
The customer reported a leaking issue that the leakage came from the connection between the tubing and the drip chamber. No patient injury or harm 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 Key6247651
MDR Text Key64736281
Report Number3006575795-2016-00137
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 Date04/01/2017
Device Model NumberB2-70071-D
Device Lot Number1404011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
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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