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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 Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: material no.364940, lot no.1035348.Bd had not received samples or photos for evaluation.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.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.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that 20 bd vacutainer® urine transfer straws had the whole tube push off the non-patient end.The following information was provided by the initial reporter: "its hard to use, and the tubes is popping of you need to hold the tube inside the holder, if not, its popping of, and it draws the urine very slow.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-09.H6: investigation summary : bd received 20 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for tube push off with the incident lot was not observed as all product specifications were met.There was no damage seen to the straw, holder, or needle.The straws were clear of debris as the needle could be seen looking down the open end of the straw.The straws were all straight and correctly attached to the holder.All holders contained a needle with the beveled edge to the outside and all needles were straight.The 20 samples were tested using water and a vacutainer tube.The straw was submerged in the water and the tube was then pushed into the holder with the needle puncturing the stopper.All samples drew water into the tubes in the correct manner.No issues with the drawing process were identified.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.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.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that 20 bd vacutainer® urine transfer straws had the whole tube push off the non-patient end.The following information was provided by the initial reporter: "its hard to use, and the tubes is popping of you need to hold the tube inside the holder, if not, its popping of, and it draws the urine very slow.".
 
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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
MDR Report Key11858187
MDR Text Key252171564
Report Number1917413-2021-00415
Device Sequence Number1
Product Code JSM
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/04/2021
Device Catalogue Number364940
Device Lot Number1035348
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2021
Date Manufacturer Received07/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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