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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET W/ PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET W/ PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 368653
Device Problems Leak/Splash (1354); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2021
Event Type  malfunction  
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.
 
Event Description
It was reported when using the bd vacutainer® push button blood collection set with pre-attached holder there was tubing separation or kink.This event occurred 25 times.The following information was provided by the initial reporter: translated to english.The customer reported that "the tubing was adhering to each other and could not be used.".
 
Manufacturer Narrative
H.6.Investigation: bd received 25 samples and 7 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for tubing stuck together with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for tubing stuck together with the incident lot was observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Based on the investigation, a most likely root cause is adhesive transfer onto the tubing from a valve.H3 other text : see h.10.
 
Event Description
It was reported when using the bd vacutainer® push button blood collection set with pre-attached holder there was tubing separation or kink.This event occurred 25 times.The following information was provided by the initial reporter: translated to english.The customer reported that "the tubing was adhering to each other and could not be used.".
 
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Brand Name
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET W/ PRE-ATTACHED HOLDER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
MDR Report Key11436488
MDR Text Key242235205
Report Number1024879-2021-00157
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903686532
UDI-Public50382903686532
Combination Product (y/n)N
PMA/PMN Number
K991088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2021
Device Model Number368653
Device Catalogue Number368653
Device Lot Number9329380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2021
Date Manufacturer Received03/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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