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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 367284
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hematoma (1884)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device lot #: reported as 20l17t2 - nipro does not have 20l17t2.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was tube push off non-patient end needle.The following information was provided by the initial reporter.The customer stated: the "tube is popping off, sometimes leaving a hematoma on the kid's arm.Some kids have to be redrawn.".
 
Manufacturer Narrative
Correction: d4: medical device lot #: 21a04t2.H6: investigation summary: bd had not received samples or photos for investigation.Therefore, 15 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to push off as all samples met specifications.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 push off.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 when using the bd vacutainer® safety-lok¿ blood collection set there was tube push off non-patient end needle.The following information was provided by the initial reporter.The customer stated: the "tube is popping off, sometimes leaving a hematoma on the kid's arm.Some kids have to be redrawn.".
 
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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
MDR Report Key12070063
MDR Text Key267158835
Report Number2243072-2021-01752
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367284
Device Lot Number21A04T2
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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