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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367256
Device Problem Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set the device disconnects and blood leaked.The following information was provided by the initial reporter.The customer stated: verbatim: when changing tubes, the device disconnects and blood leaks.There were several reports regarding the issue.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2c14a1.Medical device expiration date: 2025-03-31.Device manufacture date: 2022-07-07.Medical device lot #: 2a16a1.Medical device expiration date: 2025-01-31, device manufacture date: 2002-04-20.Medical device lot #: 2c13a1.Medical device expiration date: 2025-03-31.Device manufacture date: 2022-07-07.Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(6), nj has been listed and the (b)(6) fda registration number has been used for the manufacture report number.
 
Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to separates during use as all samples met specifications.Based on a review of the device history record for the incident lots, 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.Bd was not able to identify a root cause for the indicated failure mode.Regarding the factors at the time of use, it was surmised that the luer adapter loosened and disconnected due to some external force applied while connecting the luer adapter with the holder or during blood draw.As stated in the ifu, ¿check to ensure that the female luer adapter (a) is securely attached to the male luer adapter (b) and that the male luer adapter (b) is securely attached on the holder.¿ please be careful when using the product.
 
Event Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set the device disconnects and blood leaked.The following information was provided by the initial reporter.The customer stated: verbatim: when changing tubes, the device disconnects and blood leaks.There were several reports regarding the issue.
 
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Brand Name
BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15727096
MDR Text Key307212984
Report Number2243072-2022-01885
Device Sequence Number1
Product Code JKA
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
K991088
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 12/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367256
Device Lot Number2C13A1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/07/2022
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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