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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 B2-70071-D
Medical Device Problem Codes Leak/Splash (1354); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Information (3190)
Date of Event 01/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The affected device was not saved by the user facility.Thus, zyno medical was unable to confirm the reported leaking issue.
 
Event or Problem Description
The initial reporter reported a leaking issue of an administration set at the drip chamber to zyno medical on (b)(4) 2018:" there was another tubing that leaked just now from the same place.Just right under the barrel.B2-70071-d.Lot 1606009 201908".The initial reporter also mentioned that the failed set was not saved: "didn't know if i was going to need to send that one in as well.Next time, i will save all." no patient information was available.
 
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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 Key7207892
Report Number3006575795-2018-00017
Device Sequence Number10996219
Product Code FPA
UDI-Device Identifier00814371020150
UDI-Public00814371020150
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 Other
Type of Report Initial
Report Date (Section B) 01/12/2018
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 Date08/01/2019
Device Model NumberB2-70071-D
Device Catalogue NumberB2-70071-D
Device Lot Number1606009
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 01/12/2018
Initial Report FDA Received Date01/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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