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

Catalog Number	364979
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 that when transferring urine from urine cups with integrated transfer device into at bd vacutainer® urinalysis urine tubes, bubbles formed in the conical of the tubes which caused the instrument to read them erroneously as false positive red blood cells.The doctor recalled the patients to get retested.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: female.Event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for erroneous results with the incident lot was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for erroneous results with the incident lot was not observed.Further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Root cause description: a capa was conducted to document further investigation and root cause analysis relating to this issue.The investigation has identified the most likely root causes and corrective actions are in the process of being implemented.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue.The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.
Event or Problem Description
It was reported that when transferring urine from urine cups with integrated transfer device into at bd vacutainer® urinalysis urine tubes, bubbles formed in the conical of the tubes which caused the instrument to read them erroneously as false positive red blood cells.The doctor recalled the patients to get retested.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Common Device Name: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7739623
• Report Number: 1917413-2018-03135
• Device Sequence Number: 14088767
• Product Code: JTW
• UDI-Device Identifier: 00382903649792
• UDI-Public: 00382903649792
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 364979
• Device Lot Number: 8032646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other