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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 B2-70072
Medical Device Problem Codes Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/11/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The manufacturer has sent the affected iv set to the contract supplier on 05/05/2017.
 
Event or Problem Description
The user reported that the luer lock of the iv set broke off as she was attaching it to the patient.No patient injury or harm occurred for this case.
 
Additional Manufacturer Narrative
Zyno medical received the investigation report from the contract supplier on 05/30/2017.The user-reported complaint is confirmed and the report is attached.
 
Event or Problem Description
This is a follow-up for the initially-filed mdr (3006575795-2017-00106).
 
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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 Key6556916
Report Number3006575795-2017-00106
Device Sequence Number1010918
Product Code FPA
UDI-Device Identifier00814371020198
UDI-Public00814371020198
Combination Product (Y/N)N
Initial Reporter StateGA
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,Followup
Report Date (Section B) 05/31/2017
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 NumberB2-70072
Device Lot Number16126255
Was Device Available for Evaluation? Yes
Type of Report(Section G)FDA Requested
Initial Date Received by Manufacturer 04/11/2017
Supplement Date Received by ManufacturerNot provided
Initial Report FDA Received Date05/10/2017
Supplement Report FDA Received Date06/01/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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