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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
Model Number 367283
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
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.Oem manufacture: the manufacturing location for this product is (b)(4).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.
 
Event Description
It was reported that bd vacutainer® safety-lok¿ blood collection set was clogged.The following information was provided by the initial reporter: " when drawing the patient, the sample comes into the tubing and stops.".
 
Event Description
It was reported that bd vacutainer® safety-lok¿ blood collection set was clogged.The following information was provided by the initial reporter: " when drawing the patient, the sample comes into the tubing and stops.".
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: the manufacturing location for this product is (b)(4).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.
 
Event Description
It was reported that bd vacutainer® safety-lok¿ blood collection set was clogged.The following information was provided by the initial reporter: " when drawing the patient, the sample comes into the tubing and stops.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/13/2021.H.6.Investigation: bd received 86 samples from the customer for investigation.All samples were evaluated by visual examination and functional testing 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 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 non-conformances 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.H3 other text : see h.10.
 
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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 Key12980872
MDR Text Key285158432
Report Number2243072-2021-02899
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903672832
UDI-Public50382903672832
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K991088
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number367283
Device Catalogue Number367283
Device Lot Number1F27B1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2021
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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