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

Catalog Number 364992

Device Problem Short Fill (1575)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 with the use of the bd vacutainer® urine analysis preservative tube there was an issue with underfill.

Manufacturer Narrative

Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.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.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.

Event Description

It was reported with the use of the bd vacutainer urine analysis preservative tube there was an issue with underfill.

• Brand Name: BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8185144
• MDR Text Key: 131170067
• Report Number: 1917413-2018-03981
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649926
• UDI-Public: 50382903649926
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

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
• Device Operator: Other
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: 364992
• Device Lot Number: 8061603
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 11/30/2018
• Supplement Dates FDA Received: 01/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2018
• 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
• Patient Outcome(s): Other