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: EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
  • 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
 

EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8371
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/10/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that the patient¿s left peripheral intravenous (iv) was leaking at the hub where the one-link non-dehp y-type microbore catheter extension set was connected.This was identified when flushing.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Additional Manufacturer Narrative
Additional information was added to h3, h4, h6, h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was visually inspected and the components were observed correctly placed and according to specification.Due to the nature of the sample, no additional testing could be performed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXTENSION SETS WITH ONE-LINK NEEDLE-FREE IV CONNECTOR
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12110763
Report Number1416980-2021-04084
Device Sequence Number11907401
Product Code FPA
UDI-Device Identifier00085412091822
UDI-Public(01)00085412091822
Combination Product (Y/N)Y
Initial Reporter StateWA
Initial Reporter CountryUS
PMA/510(K) Number
K132734
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 08/17/2021
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 Catalogue Number7N8371
Device Lot NumberDR21B19079
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/07/2021
Supplement Date Received by Manufacturer08/13/2021
Initial Report FDA Received Date07/02/2021
Supplement Report FDA Received Date08/17/2021
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured02/22/2021
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
-
-