MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364943

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 01/08/2020

Event Type  malfunction  

Manufacturer Narrative

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 a molding defect was found before use with a bd vacutainer® urinalysis transfer straw kit.The following information was provided by the initial reporter, "it was reported that 8 of 20 urine preservative tubes appears to be melted or flattened.8 of 20 urine preservative tubes appears to be melted or flattened.The tubes were not crushed or cracked.Customer believes it's a manufacture issue not shipping." 8 occurrences were reported.

Manufacturer Narrative

H.6.Investigation summary bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for collapsed tubes with the incident lot was observed as all product specifications were met.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.Note that there are potentially varying degrees of tube collapse, based on the temperature and duration of time at elevated temperature.Mildly collapsed tubes will retain vacuum and only show minimal deformation.Mildly collapsed tubes will draw appropriately, but may not be able to be processed on laboratory instruments (e.G.May be slightly bowed and no longer fit in a rack).As long as the vacuum is retained and the tube fills appropriately, the tube will function properly.Fully collapsed tubes appear flattened, twisted, and visibly deformed.Fully collapsed tubes retain little or no vacuum.

Event Description

It was reported that a molding defect was found before use with a bd vacutainer® urinalysis transfer straw kit.The following information was provided by the initial reporter, "it was reported that 8 of 20 urine preservative tubes appears to be melted or flattened.8 of 20 urine preservative tubes appears to be melted or flattened.The tubes were not crushed or cracked.Customer believes it's a manufacture issue not shipping." 8 occurrences were reported.

• Brand Name: BD VACUTAINER® URINALYSIS TRANSFER STRAW KIT
• 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: 9660562
• MDR Text Key: 190508779
• Report Number: 1917413-2020-00066
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: K790366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 364943
• Device Lot Number: 9058525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other