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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 B2-70072
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Fever (1858)
Event Date 01/26/2021
Event Type  malfunction  
Manufacturer Narrative
The service provider provided the investigation report on 02/03/2021. The affected device was returned from the customer. Visual inspection confirmed that there is unknown substance in the drip chamber. The device has no physical damage. An infusion test was performed using the device and no other issue was observed. The device will be returned to the contract manufacturer for further evaluation.
 
Event Description
On (b)(6) 2021, a distributor of zyno medical reported a complaint. A user facility representative contacted the distributor on 01/27/2021 and stated that "an administration set model b2-70072 lot 20066195 set was dirty on the inside of the drip chamber". The medication being infused was vidaza. The device operator was a registered nurse. A patient was involved. The patient was not harmed. The user facility representative reported "it was the only set that we know of; when notified of it, all tubing on shelf was inspected, and all was good. " "pt had fever yesterday and today. Was tested for covid (to rule that out- was negative). Vidaza day 3 & 4 held. Pt started on augmentin. " the user facility representative also stated that "mixer and rn did not notice before (the infusion), only when disposed of, but they can't say with 100% accuracy. " on 02/02/2021, the distributor provided additional information. The set did not have any other infusion done with another medication before this infusion. The rn did not see the particles in the drip chamber at the start of the infusion. It was only noticed after the infusion completed. 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 Key11307455
MDR Text Key243811358
Report Number3006575795-2021-00003
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 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70072
Device Catalogue NumberB2-70072
Device Lot Number20066195
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2020
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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