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

Catalog Number 364992

Device Problem Volume Accuracy Problem (1675)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

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® urine analysis preservative tube, the device experienced underfilled or low draw of a tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: normally the tubes fill to the minimum required volume mark but this particular lot (2018822) fills below the minimum required volume.

Event Description

It was reported when using the bd vacutainer® urine analysis preservative tube, the device experienced underfilled or low draw of a tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: normally the tubes fill to the minimum required volume mark but this particular lot (2018822) fills below the minimum required volume.

Manufacturer Narrative

H.6.Investigation summary: mat: 364992.Lot: 2018822.No customer samples and no photos were received in support of this complaint.Therefore, 10 retention tubes from the bd inventory were visually inspected and functionally tested and no issues relating to underfill were observed.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 blood drawn into evaluated tubes varies with altitude, ambient temperature, barometric pressure, tube age, venous pressure, and filling technique.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Manufacturer Narrative

The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-24.H.6.Investigation summary: bd received 10 customer samples and 1 photo were received in support of this complaint.The photo was evaluated and shows the specimen is below the fill line on the label.The 10 customer samples were inspected with no issues being identified.Functional testing was performed on the sample tubes and the issue of underfill was not observed as all tubes were within specification limits.Additionally, 10 production lot in-house retention tubes from the bd inventory were visually inspected and functionally tested and there were no issues relating to underfill.Bd was able to confirm the customer¿s indicated failure modes of underfill based on the photo received; however, was not duplicated in the sample and retention testing.The exact cause for the customer's failure mode could not be determined.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 evacuated tubes varies with altitude, ambient temperature, barometric pressure, tube age, and filling technique.

Event Description

It was reported when using the bd vacutainer® urine analysis preservative tube, the device experienced underfilled or low draw of a tube.This event occurred once.The following information was provided by the initial reporter.The customer stated: normally the tubes fill to the minimum required volume mark but this particular lot (2018822) fills below the minimum required volume.

Manufacturer Narrative

Additional information has been received updated the following: it was reported when using the bd vacutainer® urine analysis preservative tube, the device experienced underfilled or low draw of a tube.This event occurred 200 times.The following information was provided by the initial reporter.The customer stated: normally the tubes fill to the minimum required volume mark but this particular lot (2018822) fills below the minimum required volume.Additional information was received.In total there were 1000 units of which 200 units with this problem were taken care of and there are 800 physical tubes (those that were reported).H.6.Investigation summary: bd received 1 photo in support of this complaint.The photo was evaluated and shows the specimen is below the fill line on the label.Additionally, 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.Bd was able to confirm the customer¿s indicated failure modes of underfill based on the photo received; however, was not duplicated in the retention sample testing.The exact cause for the customer's failure mode could not be determined.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 evacuated tubes varies with altitude, ambient temperature, barometric pressure, tube age, and filling technique.

Event Description

It was reported when using the bd vacutainer® urine analysis preservative tube, the device experienced underfilled or low draw of a tube.This event occurred 200 times.The following information was provided by the initial reporter.The customer stated: normally the tubes fill to the minimum required volume mark but this particular lot (2018822) fills below the minimum required volume.Additional information was received.In total there were 1000 units of which 200 units with this problem were taken care of and there are 800 physical tubes (those that were reported).

• Brand Name: BD VACUTAINER® URINE ANALYSIS PRESERVATIVE 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: 15448541
• MDR Text Key: 302609245
• Report Number: 1917413-2022-00581
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 00382903649921
• UDI-Public: 00382903649921
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K790366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 364992
• Device Lot Number: 2018822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• 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