Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM; IV ADMINISTRATION SET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZYNO MEDICAL LLC ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM; IV ADMINISTRATION SET Back to Search Results
Model Number B2-70072
Medical Device Problem Codes Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event 08/04/2023
Type of Reportable Event Malfunction
Event or Problem Description
As soon as the tubing was connected, blood began flowing back up into the line.Fluid then began leaking from the injection site.Medication was unknown.Volume to be infused was unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ZYNO MEDICAL ADMINISTRATION SET FOR Z-800 INFUSION PUMP SYSTEM
Common Device Name
IV ADMINISTRATION SET
Manufacturer (Section D)
ZYNO MEDICAL LLC
177 pine street
natick MA 01760
Manufacturer (Section G)
ZYNO MEDICAL LLC
177 pine street
natick MA 01760
Manufacturer Contact
lorraine hanley
177 pine street
natick, MA 01760
5083158230
MDR Report Key17487964
Report Number3006575795-2023-00086
Device Sequence Number7293712
Product Code FPA
UDI-Device Identifier00814371020198
UDI-Public814371020198
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K130690
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/09/2023
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 Lay User/Patient
Device Expiration Date11/02/2025
Device Model NumberB2-70072
Device Catalogue NumberB2-70072
Device Lot Number22115097
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/04/2023
Initial Report FDA Received Date08/09/2023
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
Patient SexUnknown
-
-