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

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE SYRINGE WITH 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
 

BD MEDICAL - DIABETES CARE ALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 305950
Device Problems Detachment Of Device Component (1104); Device Inoperable (1663)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that during use, a allergist tray bd safetyglide needle malfunctioned as ¿the plunger separated from the stopper, the stopper froze and would not dispense the medication. " there was no report of injury or medical intervention reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameALLERGIST TRAY WITH BD SAFETYGLIDE¿ NEEDLE
Type of DeviceSYRINGE WITH NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7274181
MDR Text Key100444841
Report Number1920898-2018-00092
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K992734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305950
Device Lot Number6298706
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/15/2018 Patient Sequence Number: 1
-
-