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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Model Number 305916
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/05/2022
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.
 
Event Description
It was reported that the bd safetyglide¿ needle was clogged.The following information was provided by the initial reporter: i've had this problem with a number of needles.It is strange because i am usually able to expel the air with no problem, it doesn't cause an issue until i'm actually injecting the vaccine.
 
Event Description
It was reported that the bd safetyglide¿ needle was clogged.The following information was provided by the initial reporter: i've had this problem with a number of needles.It is strange because i am usually able to expel the air with no problem, it doesn't cause an issue until i'm actually injecting the vaccine.
 
Manufacturer Narrative
H6: investigation summary: it was reported air would not expel from the needles.To aid in the investigation, twenty-seven samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.Twenty-five samples expelled the solution with a normal flow.Two samples did not expel the solution; these needles are clogged.A device history record review was completed for provided material number 305916, lot number 2024138.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2024138 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Previous investigations have revealed that process variations during the needle lubricant application can create clogged needles.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
 
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Brand Name
BD SAFETYGLIDE¿ NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16038093
MDR Text Key307810109
Report Number1213809-2022-01301
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K951254
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305916
Device Catalogue Number305916
Device Lot Number2024138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/05/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received01/11/2023
Supplement Dates FDA Received01/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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