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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 HEPARIN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Model Number 367960
Device Problem Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/21/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparin(lh) blood collection tubes the cover is loose.The following information was provided by the initial reporter.The customer stated: ¿after opening the cover, put it back on, the cover will come loose.¿.
 
Event Description
It was reported when using the bd vacutainer® pst¿ gel and lithium heparin(lh) blood collection tubes the cover is loose.The following information was provided by the initial reporter.The customer stated: ¿after opening the cover, put it back on, the cover will come loose¿.
 
Manufacturer Narrative
H.6.Investigation summary: mat: 367960, lot: 2042052.No sample and no photos were returned by the customer in support of this complaint.Therefore, (b)(4) retentions were visually inspected with the hemogard closure assembly correctly assembled and placed on the tubes.There were no cocked stoppers identified that would cause the hemogard closure assembly to not be applied correctly.(b)(4) retention samples were draw tested with all weights being within specification limits.No issues with the hemogard closure assembly being loose or separating during or after the draw testing was completed.Bd was unable to confirm the customer¿s indicated failure mode because no samples or photos were received, and the retention samples did not exhibit the customer¿s failure mode of ¿stopper pop off¿.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.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.H3 other text : see h.10.
 
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Brand Name
BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN BLOOD COLLECTION TUBES
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 Key15514376
MDR Text Key306275896
Report Number1917413-2022-00609
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,Followup
Report Date 09/30/2022
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 Date02/28/2023
Device Model Number367960
Device Catalogue Number367960
Device Lot Number2042052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/21/2022
Initial Date FDA Received09/30/2022
Supplement Dates Manufacturer Received09/30/2022
Supplement Dates FDA Received10/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2022
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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