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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® EDTA 2K; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® EDTA 2K; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367846
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2022
Event Type  malfunction  
Manufacturer Narrative
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® edta 2k, the device experienced a cracked tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer reported about a damage/scratch on the tube.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval?: yes.D10: returned to manufacturer on: 07-dec-2022.H6.Investigation summary: bd received 1 sample and 5 photos from the customer in support of this complaint.A visual examination of the sample and photos was performed and revealed damage to the outside of the tube.Bd was able to confirm the customer¿s indicated failure mode with the sample and photos provided.The exact cause for the customer¿s failure mode could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
 
Event Description
It was reported when using the bd vacutainer® edta 2k, the device experienced a cracked tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: the customer reported about a damage/scratch on the tube.
 
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Brand Name
BD VACUTAINER® EDTA 2K
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15902214
MDR Text Key306842773
Report Number1917413-2022-00753
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K981013
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 12/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2023
Device Catalogue Number367846
Device Lot Number2048391
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/17/2022
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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