MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINALYSIS URINE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Model Number	364979
Medical Device Problem Codes	Short Fill (1575); Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2021
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube , the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "i¿m reaching out in regards to the 10ml bd ua no additive tube.We have identified that tubes of this lot number is no longer drawing all 10ml of liquid.".
Additional Manufacturer Narrative
Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for underfill with the incident lot was not observed as the photos show liquid in the tube held up to a hand drawn chart.This product does not have a fill line.The quantity of specimen drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.The vacuum needs to be completely exhausted.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to underfill as all samples met specifications.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 of underfill.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 or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube , the device experienced underfill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "i¿m reaching out in regards to the 10ml bd ua no additive tube.We have identified that tubes of this lot number is no longer drawing all 10ml of liquid.".

• Brand Name: BD VACUTAINER URINALYSIS URINE TUBE
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 12309107
• Report Number: 1917413-2021-00720
• Device Sequence Number: 3817863
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K790366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 364979
• Device Catalogue Number: 364979
• Device Lot Number: 9344896
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1