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 PET SYRINGES VETERINARY INSULIN SYRINGE; 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 PET SYRINGES VETERINARY INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Model Number 323000
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2023
Event Type  malfunction  
Event Description
It was reported that the bd pet syringes veterinary insulin syringe was damaged.The following information was provided by the initial reporter: wanted to report this bent syringe from a lot of u-40, syringes i purchased for my dog.
 
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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-feb-2023.Investigation summary: the customer returned (1) 0.3ml 29ga vet syringe reporting damaged barrel.The syringe was visually inspected.Upon visual inspection, embecta was able to confirm the reported failure of damaged barrel.A review of the device history record was completed for batch# 2136583.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure of damaged / deformed barrel.A definitive root cause cannot be determined.H3 other text : see h10.
 
Event Description
It was reported that the bd pet syringes veterinary insulin syringe was damaged.The following information was provided by the initial reporter: wanted to report this bent syringe from a lot of u-40, syringes i purchased for my dog.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PET SYRINGES VETERINARY INSULIN SYRINGE
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 Key16358213
MDR Text Key309381631
Report Number1920898-2023-00045
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903230006
UDI-Public(01)00382903230006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 03/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number323000
Device Catalogue Number323000
Device Lot Number2136583
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-