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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER Back to Search Results
Model Number 364992
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported the bd vacutainer® urine analysis preservative tube experienced discolored/abnormal additive form.The following information was provided by the initial reporter.The customer stated " the additive looked crystallized.".
 
Manufacturer Narrative
H6: investigation summary: bd had not received samples or photos from the customer for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.
 
Event Description
It was reported the bd vacutainer® urine analysis preservative tube experienced discolored/abnormal additive form.The following information was provided by the initial reporter.The customer stated " the additive looked crystallized.".
 
Manufacturer Narrative
The following fields were updated due to additional information: h6 evluation codes: method codes: 4114; result codes: 213; conclusion codes: 67.H6: investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for additive abnormality was not observed.Bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.H3 other text : see h10.
 
Event Description
It was reported the bd vacutainer® urine analysis preservative tube experienced discolored/abnormal additive form.The following information was provided by the initial reporter.The customer stated " the additive looked crystallized.".
 
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Brand Name
BD VACUTAINER URINE ANALYSIS PRESERVATIVE TUBE
Type of Device
SPECIMEN TRANSPORT AND STORAGE CONTAINER
Manufacturer (Section D)
BECTON, DICKINSON & CO. (BROKEN BOW)
150 south 1st avenue
broken bow NE 68822
MDR Report Key10943347
MDR Text Key219493716
Report Number1917413-2020-01205
Device Sequence Number1
Product Code KDT
UDI-Device Identifier50382903649926
UDI-Public50382903649926
Combination Product (y/n)N
PMA/PMN Number
K790366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup
Report Date 02/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number364992
Device Catalogue Number364992
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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