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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 A2-80072
Medical Device Problem Codes Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/15/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The user discarded the affected administration set because it had been attached to the patient.As there is no sample available for evaluation, the manufacturer is unable to confirm the reported issue.A quality alert has been sent to the contract supplier on 07/10/2017.
 
Event or Problem Description
The user reported a leaking issue with the administration set.On (b)(6) 2017 the set leaked at male luer lock adaptor.The solution used for the infusion was ns.The tubing had been primed, when the nurse connected it to the patient, she immediately noted leakage so stopped the infusion.The patient was not adversely affected, and the tubing was changed without further problems with leakage.No patient injury or harm occured for this case.
 
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Brand Name
ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP
Common Device Name
IV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL LLC
177 pine street
natick MA 01760
MDR Report Key6725204
Report Number3006575795-2017-00171
Device Sequence Number16351603
Product Code FPA
UDI-Device Identifier00814371020112
UDI-Public00814371020112
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K132841
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberA2-80072
Device Lot Number16125141
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/05/2017
Initial Report FDA Received Date07/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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