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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
Model Number 367352
Device Problem Break (1069)
Patient Problem Bruise/Contusion (1754)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
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 has been reported that one bd vacutainer® push button blood collection set with pre-attached holder has been found with the cannula breaking off during use. The following has been provided by the initial reporter: it is reported needle broke during blood collection. Verbiage received, - bd vacutainer set with reattached holder containing 21g x 3/4 inch x 12 inch butterfly attachment lot #8323548, exp 11/30/2020: during venipuncture the needle (metal portion) broke off and had to be retrieved from entrance to vein with forceps. Metal portion of vacutainer removed intact. Pt had brief syncopal response to this event. Pt declined ultrasound to assess for any remaining foreign body. Pt reports no symptoms other than mild bruise at site of veinpuncture, states that he feels well on f/u call. Product discarded into sharps container at the time of the event.
 
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Brand NameBD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
Type of DeviceBLOOD 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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9775026
MDR Text Key186325541
Report Number1024879-2020-00148
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2020
Device Model Number367352
Device Catalogue Number367352
Device Lot Number8323548
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/02/2020 Patient Sequence Number: 1
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