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 BD INSULIN SYRINGE WITH THE 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 THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328418
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/04/2023
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 the needle broke off the bd insulin syringe with the bd ultra-fine¿ needle during use.This occurred with 2 needles.The following information was provided by the initial reporter: "consumer reported finding needles break off and stays in her site from this box only.Denied reusing of items.She was able to remove the needle on her own.".
 
Manufacturer Narrative
H6: investigation summary no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 2164525.All inspections were performed per the applicable operations qc specification.H3 other text : see h10.
 
Event Description
It was reported that the needle broke off the bd insulin syringe with the bd ultra-fine¿ needle during use.This occurred with 2 needles.The following information was provided by the initial reporter: "consumer reported finding needles break off and stays in her site from this box only.Denied reusing of items.She was able to remove the needle on her own.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16238457
MDR Text Key308082297
Report Number1920898-2023-00016
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328418
Device Lot Number2164525
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-