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; 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; IV ADMINISTRATION SET Back to Search Results
Model Number B2-70072-F
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 08/29/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Three administration set samples were tested.One set was found to have a leaking issue at filter and one set was found to have an occlusion issue at filter.The supplier will initiate corrective and preventive action to address these issues.Details can be found in the attached investigation report.(b)(4).
 
Event or Problem Description
The user originally reported an occlusion issue of the administration sets on (b)(6) 2017.During the investigation testing on (b)(6) 2017, zyno medical's contract supplier found a leaking issue with one iv set.With the new finding of the leaking issue, this complaint was determined as mdr reportable on (b)(6) 2017.The investigation report was received by zyno medical on (b)(6) 2017.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key6886161
Report Number3006575795-2017-00271
Device Sequence Number16258605
Product Code FPA
UDI-Device Identifier00814371020204
UDI-Public00814371020204
Combination Product (Y/N)N
Initial Reporter CountryMX
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) 09/15/2017
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-F
Device Catalogue NumberB2-70072-F
Device Lot Number17017533
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/12/2017
Initial Report FDA Received Date09/22/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-