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

Model Number 364979

Device Problem Short Fill (1575)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 305254909
• Report Number: 1917413-2022-00701
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1