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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367342
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/02/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® push button blood collection set tubing has a small tear.The following information was provided by the initial reporter.The customer stated: "it was reported that tubes from lot # have small tear in them.Tubing has a small tear¿.
 
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
H.6.Investigation summary: catalog number: 367342.Batch number: 0301741.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.No customer samples or photos were received for review and analysis.100 retain samples were subjected to a visual inspection for damaged tubing.2 of 100 samples failed testing resulting in evidence of damaged tubing.Therefore, this complaint can be confirmed based on retain sample testing results.30 retain samples were subjected to a submerged leak test for tubing leakage.All samples passed testing showing no evidence of tubing leakage.Therefore, this complaint cannot be confirmed based on retain sample testing results.Bd is able to confirm the customer¿s reported failure with the retain sample testing results.A definite root cause could not be determined as the defective customer sample was not received.Hole in tubing: capa pr # (b)(4) has been initiated for documentation related to this issue to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.Refer to capa pr # (b)(4) for complete documentation and action plans.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported when using the bd vacutainer® push button blood collection set tubing has a small tear.The following information was provided by the initial reporter.The customer stated: "it was reported that tubes from lot # have small tear in them.Tubing has a small tear.¿.
 
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Brand Name
BD VACUTAINER® 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 Key14190805
MDR Text Key290055908
Report Number1024879-2022-00241
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903673426
UDI-Public50382903673426
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030573
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 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2022
Device Model Number367342
Device Catalogue Number367342
Device Lot Number0301741
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
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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