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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 1 ML BD LUER SLIP TIP SYRINGE STERILE, SINGLE USE 1 ML TUBERCULIN SLIP TIP SYRIN SYRINGE, PISTON

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BECTON DICKINSON AND COMPANY 1 ML BD LUER SLIP TIP SYRINGE STERILE, SINGLE USE 1 ML TUBERCULIN SLIP TIP SYRIN SYRINGE, PISTON Back to Search Results
Model Number 309659
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
It was reported that the tuberculin 1ml slip tip syringe would not keep the hub of 30gauge x1/2in bd needle on. It was reported that the upon trying to remove the cap, the whole needle came off the slip tip. It was reported that the friction for the hub of the needle to the syringe was lacking. Fda safety report id# (b)(4).
 
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Brand Name1 ML BD LUER SLIP TIP SYRINGE STERILE, SINGLE USE 1 ML TUBERCULIN SLIP TIP SYRIN
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key12306936
MDR Text Key266202625
Report NumberMW5103138
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309659
Device Catalogue Number309659
Device Lot Number1090660
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/10/2021 Patient Sequence Number: 1
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