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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA; Syringe, piston
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BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA; Syringe, piston Back to Search Results
Model Number 320440
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
¿the customer has the bd needles in the clinic if they need to be sent in.They have been ordering these for the last 6 years and have never had an issue with them until the last 2 months.They feel this lot number or batch is bad.Their clinic goes through approximately 200 needles a day and this has been going on for 2 months.Following issues: needle sharpness-blunt.Faulty plunger.Plunger bending breaking off.End breaking off or beginning when trying to inject.Weak spots in plunger, overall not safe.Arriving with needle through the cap.Needles bent¿.
 
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Brand Name
SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA
Type of Device
Syringe, piston
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
Manufacturer (Section G)
BECTON DICKINSON AND CO.
1 becton drive
franklin lakes, 07417
Manufacturer Contact
avital merl
300 kimball dr.
parsippany, NJ 07054
MDR Report Key18806510
MDR Text Key337090684
Report Number1920898-2024-05041
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
3367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number320440
Device Lot Number3205931
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/15/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/24/2023
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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