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: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G; HYPODERMIC SINGLE LUMEN NEEDLE
  • 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 MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 305916
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/08/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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 while using bd safetyglide¿ needle only, 25 g the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: staff have indicated at least x 10 that they are not able to push the air out of the needle.
 
Event Description
It was reported while using bd safetyglide¿ needle only, 25 g the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: staff have indicated at least x 10 that they are not able to push the air out of the needle.
 
Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16055992
MDR Text Key308476247
Report Number1213809-2022-01313
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K951254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305916
Device Catalogue Number305916
Device Lot Number2024137
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-