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: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM PISTON SYRINGE
  • 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 SYRINGE 0.3ML 30GA 8MM PISTON SYRINGE Back to Search Results
Catalog Number 326638
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device lot # unknown. Medical device expiration date : unknown. Initial reporter zip code : (b)(6). A device evaluation is pending but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Medical device manufacture date : unknown.
 
Event Description
It was reported that 1 bd syringe 0. 3ml 30ga 8mm hub separated from the device. The following information was provided by the initial reporter : the customer reported about needle/shield separation from the barrel when removing the orange shield.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 0.3ML 30GA 8MM
Type of DevicePISTON SYRINGE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11953604
MDR Text Key257413472
Report Number1920898-2021-00644
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number326638
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 Received06/23/2021
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

-
-