MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® URINALYSIS CONCIAL URINE TUBE NO ADDITIVE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364980

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 that 8 bd vacutainer® urinalysis concial urine tubes with no additive had "spots" inside them similar to "condensation".

Manufacturer Narrative

Investigation summary: bd received samples and photos were provided by the customer facility for investigation.The samples and photos were evaluated and the customer's indicated failure mode for foreign matter with the incident lot was 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.Investigation conclusion: based on evaluation of the customer samples and photos, the customer¿s indicated failure mode for foreign matter with the incident lot was observed.Root cause description: based on the investigation, a root cause could not be determined.

Event Description

It was reported that 8 bd vacutainer® urinalysis concial urine tubes with no additive had "spots" inside them similar to "condensation".

• Brand Name: BD VACUTAINER® URINALYSIS CONCIAL URINE TUBE NO ADDITIVE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8322285
• MDR Text Key: 136115257
• Report Number: 1917413-2019-00192
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 364980
• Device Lot Number: 8099568
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other