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

Catalog Number	364979
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd vacutainer® urinalysis urine tubes are underfilling.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that bd vacutainer urinalysis urine tubes are underfilling.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.It has been corrected from the initial mdr to (b)(6) 2018 when bd employee first made aware of issue.
Event or Problem Description
It was reported that bd vacutainer urinalysis urine tubes are underfilling.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.However, bd has initiated further investigation relating to this issue through a capa.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation has been initiated through a capa.The investigation is still on-going and improvements will be made as the potential causes are identified.Although no samples or photos were available for evaluation, bd has initiated further investigation through a capa to identify the potential root cause(s).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 and implement corrective actions.The investigation is currently on-going and further improvements will be made as the potential root cause(s) are identified.

• 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: 7906278
• Report Number: 1917413-2018-03496
• Device Sequence Number: 11266321
• Product Code: JTW
• UDI-Device Identifier: 00382903649792
• UDI-Public: 382903649792
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2018

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 Catalogue Number: 364979
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 08/31/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/10/2018; 10/29/2018
• 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