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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 Problems Device Damaged Prior to Use (2284); Physical Property Issue (3008)
Patient Problem Not Applicable (3189)
Event Date 02/07/2017
Event Type  malfunction  
Manufacturer Narrative
The failed iv set was sent to the contract supplier for evaluation on 02/28/2017. The manufacturer is still waiting for the results and will actively follow up on this investigation.
 
Event Description
The user reported that the iv set came out in pieces when she opened up the package. No patient was involved in this case.
 
Manufacturer Narrative
Zyno medical has received the investigation report from the contract manufacturer on 04/28/2017. The user-reported complaint was confirmed.
 
Event Description
This is a follow-up for the initially filed mdr (3006575795-2017-00059).
 
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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 Key6379068
MDR Text Key69104304
Report Number3006575795-2017-00059
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K132841
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70072
Device Lot Number16107204
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2017
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
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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