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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® STANDARD YELLOW HOLDER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® STANDARD YELLOW HOLDER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 364879
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.Medical device expiration date: na.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® standard yellow holder, there was mixed product in the shipping box.The following information was provided by the initial reporter.The customer stated: holder standard yellow b (4 sachets of 250) in a box (bx) (364879) - ddp 31/12/25.Pronto reusable self-picking body (box of 20) (368872) - 31/12/99.
 
Event Description
It was reported when using the bd vacutainer® standard yellow holder, there was mixed product in the shipping box.The following information was provided by the initial reporter.The customer stated: holder standard yellow b (4 sachets of 250) in a box (bx) (364879) - ddp 31/12/25.Pronto reusable self-picking body (box of 20) (368872) - 31/12/99.
 
Manufacturer Narrative
After further evaluation of the complaint, it has been determined that this supplemental is to cancel mfg report#: 1024879-2022-00664 due to confirmation that there has been no claim of an alleged failure.
 
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Brand Name
BD VACUTAINER® STANDARD YELLOW 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15781281
MDR Text Key305808528
Report Number1024879-2022-00664
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
PREAMENDMENT
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 11/15/2022
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 Other
Device Catalogue Number364879
Device Lot Number1532193
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2022
Initial Date FDA Received11/11/2022
Supplement Dates Manufacturer Received11/15/2022
Supplement Dates FDA Received11/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2022
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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