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

Catalog Number 364992

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/25/2019

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 cracked tube and foreign matter were found before use with a bd vacutainer® urine analysis preservative tube.The following information was provided by the initial reporter, "the tube was cracked.Lot: unknown.Looks scratch not crack.(fm) hair".

Manufacturer Narrative

H.6 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 damaged and biological foreign matter with the incident lot was observed.Additionally, evaluation of the customer samples was performed and damaged and biological foreign matter 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.

Event Description

It was reported that a cracked tube and foreign matter were found before use with a bd vacutainer® urine analysis preservative tube.The following information was provided by the initial reporter, "the tube was cracked.Lot: unknown looks scratch not crack.(fm) hair ".

• Brand Name: BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE
• 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: 9700742
• MDR Text Key: 188053307
• Report Number: 1917413-2020-00108
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649926
• UDI-Public: 50382903649926
• 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: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 364992
• Device Lot Number: SEE. H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other