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 VEO¿ 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 VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 324906
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2021
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 liquid was seen inside the bd veo¿ insulin syringe with the bd ultra-fine¿ needle, and drops of it came out of the needle when the plunger was depressed.The following information was provided by the initial reporter: "consumer returned my call and stated that there is liquid inside of the syringe.She stated that when she depressed the plunger rod, drops of the liquid came through the needle." "consumer reported seeing liquid inside of the needles after removing the shield.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10/4/2021.H.6.Investigation: customer returned (6) loose 3/10cc, 6mm syringes.Customer states that there is liquid inside of the syringe.Three out of 6 returned syringes were tested and all 3 exhibited a clear drop of material coming out of the cannula when the plunger rod was fully depressed.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely silicone.A review of the device history record was completed for batch # 0177612 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause for this defect cannot be determined.H3 other text : see h.10.
 
Event Description
It was reported that liquid was seen inside the bd veo¿ insulin syringe with the bd ultra-fine¿ needle, and drops of it came out of the needle when the plunger was depressed.The following information was provided by the initial reporter: "consumer returned my call and stated that there is liquid inside of the syringe.She stated that when she depressed the plunger rod, drops of the liquid came through the needle." "consumer reported seeing liquid inside of the needles after removing the shield.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD VEO¿ 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12595301
MDR Text Key275427065
Report Number1920898-2021-01052
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249060
UDI-Public00382903249060
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 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number324906
Device Catalogue Number324906
Device Lot Number0177612
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-