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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 WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 368659
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2024
Event Type  malfunction  
Manufacturer Narrative
D.2.Medical device type: one additional code applies, jka g5: pma/510(k)#: one additional code applies; k220212 h.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that during the use of bd vacutainer® push button blood collection set with pre-attached holder, the blood enters the tubing really fast when the needle was inserted into the patient.Then when the vacutainer tube was connected, it shoots the blood in really quickly and loses all pressure; it stops working.No patient impact reported.
 
Event Description
It was reported that during the use of bd vacutainer® push button blood collection set with pre-attached holder, the blood enters the tubing really fast when the needle was inserted into the patient.Then when the vacutainer tube was connected, it shoots the blood in really quickly and loses all pressure; it stops working.No patient impact reported.
 
Manufacturer Narrative
The following information has been updated with corrected and/or additional information: d.9.Device available for eval? yes.D.9.Returned to manufacturer on: 06-mar-2024.H.6.Investigation summary: "material #: 368659.Lot/batch #: 2297392.Bd received 1 sample and 1 photo for investigation.The photo was reviewed, and it shows the unit packaging of the device, confirming the lot number.Additionally, the customer sample along with 30 retention samples from bd inventory were evaluated by functional draw testing and the indicated failure mode for insufficient flow with the incident lot was not 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.This complaint is unable to be confirmed for the indicated failure mode insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer (Section G)
BECTON, DICKINSON & CO., (BD)
1575 airport road
sumter SC 29153
Manufacturer Contact
jo doyka
7 loveton circle
sparks, MD 21152
4103164000
MDR Report Key18817530
MDR Text Key337534274
Report Number1024879-2024-00189
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030573
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 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number368659
Device Lot Number2297392
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2022
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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