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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; TRANSPORT CULTURE MEDIUM
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BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE TRANSFER STRAW; TRANSPORT CULTURE MEDIUM Back to Search Results
Catalog Number 364940
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na 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 that during use bd vacutainer® urine transfer straw fluid was unable to rise through the straw.The following information was provided by the initial reporter, translated from french to english: "in that case why can't we get the fluid to rise properly in the cannula?".
 
Event Description
It was reported that during use bd vacutainer® urine transfer straw fluid was unable to rise through the straw.The following information was provided by the initial reporter, translated from french to english: "in that case why can't we get the fluid to rise properly in the cannula?".
 
Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos for evaluation.No retentions are kept for product 364940; therefore, the investigation was limited.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.
 
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Brand Name
BD VACUTAINER® URINE TRANSFER STRAW
Type of Device
TRANSPORT CULTURE MEDIUM
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
8448235433
MDR Report Key16675351
MDR Text Key313513645
Report Number1917413-2023-00255
Device Sequence Number1
Product Code JSM
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
NA
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 07/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number364940
Device Lot Number2187379
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/06/2022
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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