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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 Code Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 02/07/2013
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A) the user-reported separation issue was confirmed.B) the complaint was determined as not mdr reportable at the initial determination by following company procedures.This mdr is retrospectively filed as a corrective action to address one of the fda inspection observations made on 08/11/2016.C) zyno medical submitted an e-mdr (3006575795-2016-00117_complaint (b)(4)) on 10/26/2016 through the fda's website and received the receipt.But due to some technical difficulties and confusion, the file didn't pass with all three acknowledgements.This is a re-submission regarding the same event.
 
Event or Problem Description
The customer reported that the tubing came apart at the drip chamber.No patient 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 Key6247813
Report Number3006575795-2016-00117
Device Sequence Number16370430
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) 01/13/2017
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 Number55037KS
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/12/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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