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 SYRINGES 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 SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328418
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Event Description
It was reported that the stopper of the bd insulin syringes with bd ultra-fine¿ needles was deformed.The following information was provided by the initial reporter: the "stopper" looks "melted" inside the barrel.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 2052428.All inspections and challenges and challenges were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h10.
 
Event Description
It was reported that the stopper of the bd insulin syringes with bd ultra-fine¿ needles was deformed.The following information was provided by the initial reporter: the "stopper" looks "melted" inside the barrel.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD INSULIN SYRINGES WITH 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 Key15017175
MDR Text Key301979215
Report Number1920898-2022-00451
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328418
Device Lot Number2052428
Was Device Available for Evaluation? No
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-