• 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 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE 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 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE Back to Search Results
Model Number 328438
Device Problems Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)
Patient Problem Needle Stick/Puncture (2462)
Event Date 09/02/2020
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown a device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown fda device problem code(s): 2979, 1504. Fda patient problem code(s): 2462.
 
Event Description
It was reported that an unspecified number of bd insulin syringe with bd ultra-fine¿ needle experienced product damage while still considered operable during use. The product defect resulted in a needle stick injury to the device operator. It has not been specified whether any medical intervention/testing was administered as a result. The following information was provided by the initial reporter: material no: 328438 batch no: unknown (provided 0041302) after administering epoetin alfa on another individual i went to replace the orange cap on the needle. The tip of the needle went through the orange cap and pricked my finger.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key10570838
MDR Text Key208088528
Report Number1920898-2020-01283
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number328438
Device Catalogue Number328438
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 Received09/02/2020
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

Patient Treatment Data
Date Received: 09/22/2020 Patient Sequence Number: 1
-
-