• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON 60 IN NON-DEHP MICROBORE EXTENSION SET INTRAVASCULAR 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
 

BECTON DICKINSON 60 IN NON-DEHP MICROBORE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number ME2020
Device Problem Leak/Splash (1354)
Patient Problems Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914)
Event Date 05/31/2021
Event Type  malfunction  
Manufacturer Narrative
"unknown manufacturer: (b)(4). A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. ".
 
Event Description
It was reported that a 60 in non-dehp microbore extension set experienced tubing separation, and damage during use. The following was reported by the initial reporter: "microbore extension seems to be issues with the leur lock collar coming off or unattached and sometimes cracking. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name60 IN NON-DEHP MICROBORE EXTENSION SET
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12097353
MDR Text Key259431222
Report Number2243072-2021-01793
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberME2020
Device Catalogue NumberME2020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-