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: IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRA
  • 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
 

IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRA Back to Search Results
Model Number V1390
Medical Device Problem Code Improper Flow or Infusion (2954)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
 
Event or Problem Description
As reported by the user facility: "clamp makes it difficult to regulate the flow of fluid and once set and we leave and return, we find our infusion rates have changed (faster than it was set for)." no injury reported.
 
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Further investigation of the report is not possible.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IV ADMINISTRATION SET
Common Device Name
SET, ADMINISTRATION, INTRA
MDR Report Key12157458
Report Number2523676-2021-00205
Device Sequence Number3768569
Product Code FPA
UDI-Device Identifier04046964188176
UDI-Public04046964188176
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K173361
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 08/28/2021
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 Date02/28/2026
Device Model NumberV1390
Device Catalogue NumberV1390
Device Lot Number0061773021
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 06/28/2021
Supplement Date Received by Manufacturer06/28/2021
Initial Report FDA Received Date07/13/2021
Supplement Report FDA Received Date08/28/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/30/2021
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 Initial
Patient Sequence Number1
-
-