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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 Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/13/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
User reported issue was confirmed.Quality alert was sent to the supplier on 02/24/2016.Affected iv sets are under recall #(b)(4).(b)(4).
 
Event or Problem Description
The user had 2 incidents of leaking at the filter on a2-80071-df (iv set) both lot #1410004.No patients were injured but the user did have chemo spill onto the floor.
 
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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 Key6234093
Report Number3006575795-2016-00149
Device Sequence Number16224131
Product Code FPA
UDI-Device Identifier00814371020075
UDI-Public00814371020075
Combination Product (Y/N)N
Initial Reporter StateOH
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
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 01/09/2017
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 Date12/01/2017
Device Model NumberA2-80071-DF
Device Lot Number1410004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/20/2016
Initial Report FDA Received Date01/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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