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
Model Number 324909
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/23/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that foreign residue was found in the bd insulin syringe with the bd ultra-fine¿ needle that came out when pressing the plunger.The following information was provided by the initial reporter: "consumer reported that there was some type of residue inside of the syringe, she stated that when she pressed down on the plunger rod a small amount of liquid came out.".
 
Event Description
It was reported that foreign residue was found in the bd insulin syringe with the bd ultra-fine¿ needle that came out when pressing the plunger.The following information was provided by the initial reporter: "consumer reported that there was some type of residue inside of the syringe, she stated that when she pressed down on the plunger rod a small amount of liquid came out.".
 
Manufacturer Narrative
H6: investigation summary customer returned (3) 3/10cc, 6mm, 31g syringes in an open poly bag from lot # 0189390.Customer states that there was some type of residue inside of the syringe, she stated that when she pressed down on the plunger rod a small amount of liquid came out.All returned syringes were examined and no visible liquid was observed in the barrels of the syringes.All syringes were also tested and no liquid came out of the cannula when fully depressing the plunger rod.A review of the device history record was completed for batch # 0189390 all inspections were performed per the applicable operations qc specifications.There were (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
 
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
MDR Report Key11369526
MDR Text Key251439891
Report Number1920898-2021-00207
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903249091
UDI-Public00382903249091
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number324909
Device Catalogue Number324909
Device Lot Number0189390
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/09/2021
Date Manufacturer Received03/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-