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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; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 367365
Device Problem Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2023
Event Type  malfunction  
Manufacturer Narrative
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 while using an unspecified bd vacutainer® push button blood collection set the safety sheath did not fully enclose the needle when activated leaving the used needle exposed.The following information was provided by the initial reporter: needle safety sheath not fully enclosing the needle, when activated.One incident of the needle safety sheath not fully enclosing the needle, when activated.Hence, the used needle was still exposed.
 
Manufacturer Narrative
The following fields were updated: d9.Device available for evaluation? yes returned to manufacturer on: 06-jun-2023, h6.Investigation summary: bd received 5 samples for investigation.The samples were evaluated by retraction lockout testing and the indicated failure mode for partial retraction with the incident lot was not observed as all product specifications were met.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 partial retraction.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.
 
Event Description
It was reported that while using an unspecified bd vacutainer® push button blood collection set the safety sheath did not fully enclose the needle when activated leaving the used needle exposed.The following information was provided by the initial reporter: needle safety sheath not fully enclosing the needle, when activated.One incident of the needle safety sheath not fully enclosing the needle, when activated.Hence, the used needle was still exposed.
 
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Brand Name
BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17084540
MDR Text Key316754619
Report Number1024879-2023-00358
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50382903673655
UDI-Public50382903673655
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number367365
Device Catalogue Number367365
Device Lot Number2230727
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/06/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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