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 Code	Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "when the urine tube is inserted there is no blood flow.".
Additional Manufacturer Narrative
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 there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "when the urine tube is inserted there is no blood flow.".
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 2 contaminated samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for underfill with the incident lot was not observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing and the issue of underfill was not observed.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 unable to confirm the customer¿s indicated failure mode with the contaminated sample as it was used for a blood draw and not used for transporting urine.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 h.10.
Additional Manufacturer Narrative
The following fields have been updated with additional information: d.4.Medical device lot #: 1228966.D.4 medical device expiration date: 2023-08-31.H.4.Device manufacture date: 2021-08-16.
Event or Problem Description
It was reported when using the bd vacutainer® urinalysis urine tube there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: "when the urine tube is inserted there is no blood flow.".

• 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
• 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 Key: 15141347
• Report Number: 1917413-2022-00442
• Device Sequence Number: 5614483
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2022

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Model Number: 364979
• Device Catalogue Number: 364979
• Device Lot Number: 1228966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 08/24/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 08/08/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown