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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 A2-80071-DF
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/02/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The iv set was discarded by the user and not returned to the manufacturer for evaluation.The complaint cannot be confirmed.Upon receiving the complaint, it was initially determined as not reportable by the manufacturer.During the final review of the complaint file by quality/ management, it was determined as mdr reportable on 01/13/2017.This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on 08/11/2016.
 
Event or Problem Description
The user reported a leaking issue that the tubing "leak just below the filter housing".No patient injury or harm was involved in 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 Key6258593
Report Number3006575795-2016-00166
Device Sequence Number452976
Product Code FPA
UDI-Device Identifier00814371020075
UDI-Public00814371020075
Combination Product (Y/N)N
Initial Reporter StateTX
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) 01/17/2017
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 Expiration Date10/01/2017
Device Model NumberA2-80071-DF
Device Lot Number1410014
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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