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
Model Number 328440
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2023
Event Type  malfunction  
Event Description
It was reported that 94 bd insulin syringes with bd ultra-fine¿ needle experienced scale marking issue.The following information was provided by the initial reporter: the customer notices that when pushing the plunger to the bottom of syringe, the seal align to '0' is not accurate.Some of them above '0', some of them in the middle of '0', and some of them below '0'.Please refer to the pictures.She is worried that the injection volume will be affect, so she will check the syringe before using.Currently, she only uses the syringe which seal align below '0'.
 
Manufacturer Narrative
E1.Initial reporter addr 1: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-jun-2023.H6: investigation summary: customer returned one shelf carton from lot# 1333189 with (3) 0.3ml x 31g x 8mm syringes in a clear ziploc and (90) 0.3ml x 31g x 8mm syringes in 6 open polybags.The returned syringes were visually examined and observed no issues.The (30) syringes were inspected via gauge to ensure correct placement of the graduation markings and observed the return samples found to be within permitted specifications.Hence, the reported issue could not be confirmed based on the samples return for investigation.The root cause could not be determined because the issue could not be confirmed.A review of the device history record was completed for batch# 1333189.All inspections and challenges were performed per the applicable operations qc specifications.H3 other text : see h10.
 
Event Description
It was reported that 94 bd insulin syringes with bd ultra-fine¿ needle experienced scale marking issue.The following information was provided by the initial reporter: the customer notices that when pushing the plunger to the bottom of syringe, the seal align to '0' is not accurate.Some of them above '0', some of them in the middle of '0', and some of them below '0'.Please refer to the pictures.She is worried that the injection volume will be affect, so she will check the syringe before using.Currently, she only uses the syringe which seal align below '0'.
 
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
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key16747033
MDR Text Key313392593
Report Number1920898-2023-00229
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908440035
UDI-Public(01)00382908440035
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K212499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/28/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number328440
Device Catalogue Number328440
Device Lot Number1333189
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-