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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
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BD BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION Back to Search Results
Model Number 367342
Device Problems Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506); Fail-Safe Problem (2936)
Patient Problem Needle Stick/Puncture (2462)
Event Date 08/10/2022
Event Type  malfunction  
Event Description
New butterfly needles for lab draws are difficult to use causing needlestick.Needle was clean; so no intervention for employee.23 g butterfly needles from greiner bio-one are difficult to use.Tubing is shorter so hard to maneuver.Once stuck happened, unable to close needle, difficult to snap close to dispose of.Almost stuck myself again because it was not clear how to snap shut needle.Potential safety issue if needle used already.Luckily this was a clean needle.
 
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Brand Name
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
Type of Device
TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
Manufacturer (Section D)
BD
5859 farinon dr.,
ste 200
san antonio, TX 78249
MDR Report Key15833642
MDR Text Key304017229
Report Number15833642
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2022
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 Health Professional
Device Model Number367342
Device Catalogue Number367342
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/09/2022
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer11/21/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/21/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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