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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 367392
Device Problem Leak/Splash (1354)
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® ultratouch¿ push button blood collection set, the device experienced poor sleeve function.The following information was provided by the initial reporter.The customer stated: after successful puncture, blood began to flow out of the puncture needle tube before the blood collection vessel was connected.The blood collection vessel was quickly connected for blood collection.In the process of replacing the blood collection vessel, blood still flowed out from the black rubber at the end of the blood collection needle.Patients and users were not affected.
 
Manufacturer Narrative
There were multiple device types reported to be involved.The information for the additional device types are as follows.Medical device type: jka / fpa.Common device name: blood specimen collection device; intravascular administration set.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.3.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing and no issues were observed relating to leakage 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 leakage.Bd was not able to identify a root cause for the indicated failure mode.
 
Event Description
It was reported when using the bd vacutainer® ultratouch¿ push button blood collection set, the device experienced poor sleeve function.The following information was provided by the initial reporter.The customer stated: after successful puncture, blood began to flow out of the puncture needle tube before the blood collection vessel was connected.The blood collection vessel was quickly connected for blood collection.In the process of replacing the blood collection vessel, blood still flowed out from the black rubber at the end of the blood collection needle.Patients and users were not affected.
 
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Brand Name
BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
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 Key15697603
MDR Text Key304820395
Report Number1024879-2022-00631
Device Sequence Number1
Product Code JKA
UDI-Device Identifier00382903673926
UDI-Public00382903673926
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K153309
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 11/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2023
Device Catalogue Number367392
Device Lot Number1340012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2021
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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