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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367960
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/24/2022
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no samples and no photos were returned by the customer in support of this complaint.Therefore, 10 retention samples from the bd inventory were visually inspected and functionally tested and the customer's indicated failure mode of decapping was not observed as all tubes were within specification limits and did not exhibit decapping.Bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were returned.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
 
Event Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparinn (lh) blood collection tube there was stopper creep out or loose closure.The following information was provided by the initial reporter.The customer stated: "the bottle cap was loose.".
 
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Brand Name
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE
Type of Device
BLOOD SPECIMEN COLLECTION DEVICE
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer (Section G)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key14719233
MDR Text Key297458260
Report Number1917413-2022-00325
Device Sequence Number1
Product Code JKA
UDI-Device Identifier50382903679602
UDI-Public50382903679602
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K945952
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
Report Date 05/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2022
Device Model Number367960
Device Catalogue Number367960
Device Lot Number1350376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/24/2022
Initial Date FDA Received06/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2021
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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