MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) 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 02/11/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(4).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 foreign "spots", similar to the consistency of condensation, were present in 7 of the bd vacutainer® urinalysis concial urine tubes with no additive, and discovered before use.As reported by the customer, translated from spanish to english, "it presents spots inside like it had any additive, seem to spots of condensation.".

Manufacturer Narrative

Investigation summary: bd received samples and photos from the customer facility for investigation.The photos were evaluated and the customer¿s indicated failure mode for foreign matter with the incident lot was not observed.Additionally, evaluation/testing of the customer samples was performed and foreign matter 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.Investigation conclusion: based on evaluation of the customer samples, the customer¿s indicated failure mode for foreign matter with the incident lot was not observed as all samples met the required specifications.Additionally, the photos did not identify a specific product issue.Root cause description: based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that foreign "spots", similar to the consistency of condensation, were present in 7 of the bd vacutainer® urinalysis concial urine tubes with no additive, and discovered before use.As reported by the customer, translated from spanish to english, "it presents spots inside like it had any additive, seem to spots of 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. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8396253
• MDR Text Key: 139444564
• Report Number: 1917413-2019-00376
• 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: 03/27/2019

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: 12/31/2019
• Device Catalogue Number: 364980
• Device Lot Number: 8156642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 02/19/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other