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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 SYSTEM IV ADMINISTRATION SET

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ZYNO MEDICAL, LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM IV ADMINISTRATION SET Back to Search Results
Model Number B2-70070
Device Problems Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  malfunction  
Manufacturer Narrative
The affected sets were discarded by the user. The complaint couldn't be confirmed.
 
Event Description
On (b)(6) 2021, a distributor of zyno medical reported a complaint. "customer stated that the items have holes in them and blood comes out. Customer only had the lot number and no more information on the items. " a patient was involved but was not harmed or injured. The device operator was a registered nurse. The medication being infused was unknown. The contract manufacturer of the affected device is becton, dickinson and company.
 
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Brand NameZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
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
MDR Report Key12331110
MDR Text Key266878679
Report Number3006575795-2021-00039
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 distributor,health profession
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70070
Device Catalogue NumberB2-70070
Device Lot Number20085505
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/24/2020
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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