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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 B2-70071-DF
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2022
Event Type  malfunction  
Manufacturer Narrative
Zyno medical is waiting for the arrival of the affected device.
 
Event Description
On (b)(6) 2022, zyno medical received a complaint from an end user regarding a leaking issue. It was reported that "the leak was coming from below the bottom filter on the tubing, and it would happen immediately. " the end user also stated that "this event took place 4 times in a single day all on (b)(6) 2022". The device operator was a nurse. Medication being infused was remicade. There was a patient involved. The patient was not harmed or injured. 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 Key14014031
MDR Text Key289278780
Report Number3006575795-2022-00008
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 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2-70071-DF
Device Catalogue NumberB2-70071-DF
Device Lot Number21065899
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2021
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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