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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367300
Device Problem Disconnection (1171)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® multiple sample luer adapter, the device experienced the non-patient needle separating from the holder.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: the luer adapter fits loosely on the non-return valve of the catheter used in the er, the catheter is braum brand.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Returned to manufacturer on: 2022-08-11.Bd received (b)(4) samples and a photo for investigation.The photos were reviewed and the customer¿s indicated failure mode for loose fit with the incident lot was not observed.The photo showed a luer adapter device that was unopened and unusued.Additionally, the customer samples were evaluated by functional testing and the indicated failure mode for loose fit with the incident lot was not observed as all product specifications were met.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 of loose fit.Bd was not able to identify a root cause for the indicated failure mode.Our business team regularly reviews the collected data for identification of emerging trends.".
 
Event Description
It was reported when using the bd vacutainer® multiple sample luer adapter, the device experienced the non-patient needle separating from the holder.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: the luer adapter fits loosely on the non-return valve of the catheter used in the er, the catheter is braum brand.
 
Event Description
It was reported when using the bd vacutainer® multiple sample luer adapter, the device experienced the non-patient needle separating from the holder.This event occurred eleven times.The following information was provided by the initial reporter.The customer stated: the luer adapter fits loosely on the non-return valve of the catheter used in the er, the catheter is braum brand.
 
Manufacturer Narrative
The following fields have been updated with additional information: b5.Describe event or problem: it was reported when using the bd vacutainer® multiple sample luer adapter, the device experienced the non-patient needle separating from the holder.This event occurred eleven times.The following information was provided by the initial reporter.The customer stated: the luer adapter fits loosely on the non-return valve of the catheter used in the er, the catheter is braum brand.D.4.Medical device lot #: 1252106.D.4 medical device expiration date: 2024-08-31.H.4.Device manufacture date: 2021-09-09.
 
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Brand Name
BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
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 Key14114228
MDR Text Key289324281
Report Number1024879-2022-00218
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeSP
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,Followup
Report Date 08/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number367300
Device Lot Number1252106
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2021
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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