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

Catalog Number 365017

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

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

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® urinalysis preservative urine tube 12 were received completely bowed.

Event Description

It was reported that bd vacutainer® urinalysis preservative urine tube 12 were received completely bowed.

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 collapsed tubes with the incident lot was observed.Additionally, evaluation of the customer samples was performed and collapsed tubes 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 photos, the customer¿s indicated failure mode for collapsed tbes with the incident lot was observed.Additionally, evaluation/testing of the customer samples was conducted and collapsed observed.Root cause description: based on the investigation, a root cause could not be determined.

• Brand Name: BD VACUTAINER® URINALYSIS PRESERVATIVE URINE TUBE
• 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: 8237690
• MDR Text Key: 132798891
• Report Number: 1917413-2018-04146
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 365017
• Device Lot Number: 7305520
• Date Manufacturer Received: 12/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other