MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER URINE COMPLETE CUP KIT; TRANSPORT CULTURE MEDIUM

Catalog Number 364957

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

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.(b)(4).

Event Description

It was reported when using the bd vacutainer® urine complete cup kit there was under-fill or low draw.The following information was provided by the initial reporter.The customer stated: "the tubes were underfilling." received call from laboratory manager that reports "facility noticing.5 ml away from minimum fill line.He states only 10 instances within a months time.No specific date of event.Facility has to recollect patient's urine with no issues.Facility is sitting at 7,000 feet elevation.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/19/2021.H.6.Investigation: no customer samples from catalog 364957, lot number 0120087 were returned for this complaint; however, 2 customer samples from catalog 364957, lot number 0120087 were returned for a related complaint.No photos were returned to be evaluated.Draw testing was performed and all tubes were within specification limits.Bd was unable to confirm the customer¿s indicated failure mode because the defect was not observed in the customer sample testing.Based on the investigation results to date, root cause was not determined.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.

Event Description

It was reported when using the bd vacutainer® urine complete cup kit there was under-fill or low draw.The following information was provided by the initial reporter.The customer stated: "the tubes were underfilling." received call from laboratory manager that reports "facility noticing.5 ml away from minimum fill line.He states only 10 instances within a months time.No specific date of event.Facility has to recollect patient's urine with no issues.Facility is sitting at 7,000 feet elevation.".

• Brand Name: BD VACUTAINER URINE COMPLETE CUP KIT
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11359367
• MDR Text Key: 232873683
• Report Number: 1917413-2021-00109
• Device Sequence Number: 1
• Product Code: JSM
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 364957
• Device Lot Number: 0120087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1