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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION TUBE; BLOOD SPECIMEN COLLECTION DEVICE Back to Search Results
Catalog Number 362780
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/24/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube, the device experienced glass tubing breaking while in the centrifuge.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: tube breakage, they have had two separate occasions where tubes broke in the centrifuge.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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: no samples or photos were returned by the customer in support of this complaint from catalog 362780, lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.
 
Event Description
It was reported when using the bd vacutainer® cpt¿ mononuclear cell preparation tube, the device experienced glass tubing breaking while in the centrifuge.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: tube breakage, they have had two separate occasions where tubes broke in the centrifuge.
 
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Brand Name
BD VACUTAINER® CPT¿ MONONUCLEAR CELL PREPARATION 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 Key15738496
MDR Text Key307627370
Report Number1917413-2022-00686
Device Sequence Number1
Product Code JCF
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K891407
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 11/23/2022
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 Catalogue Number362780
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/24/2022
Initial Date FDA Received11/04/2022
Supplement Dates Manufacturer Received12/01/2022
Supplement Dates FDA Received12/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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