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	10/26/2022
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 there was under-fill or low draw of a tube with blood.The following information was provided by the initial reporter.The customer stated: pressure was lost during the first stick.In a bd sponsored trial study, the product 364979, lot# 1074704 reported to have vacuum pressure loss during the first attempt.
Additional Manufacturer Narrative
H.6.Investigation summary: no customer samples or photos were received in support of this complaint.Therefore, 10 production lot in-house retention tubes from the bd inventory were visually inspected and functionally tested and the issue of underfill was not observed as all tubes were within specification limits.Bd was unable to confirm the customer¿s indicated failure modes of underfill based on the investigation completed.No samples were received, and the defect was not observed in the retention sample testing.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.The quantity of specimen drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, and filling technique.
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: pressure was lost during the first stick.In a bd sponsored trial study, the product 364979, lot# 1074704 reported to have vacuum pressure loss during the first attempt.

• 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: 15760007
• Report Number: 1917413-2022-00701
• Device Sequence Number: 6226642
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Study,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 03/31/2023
• Device Model Number: 364979
• Device Catalogue Number: 364979
• Device Lot Number: 1074704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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