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

Catalog Number 364979

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

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

Event Date 10/06/2017

Event Type  malfunction  

Manufacturer Narrative

Bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode with the incident lot was observed.Additionally, a review of the manufacturing records was completed for the incident lot and no issues were identified.Bd received samples from the customer facility for investigation.This complaint is confirmed to be within the scope of a known issue.Quality has previously reviewed, evaluated and investigated this failure mode.No further action is required at this time.Based on evaluation of the complaint information, this complaint meets the criteria for a previously investigated complaint; reference (b)(4).

Event Description

It was reported that bd vacutainer® urinalysis urine tubes were crushed.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® URINALYSIS URINE TUBE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7569549
• MDR Text Key: 110276680
• Report Number: 1917413-2018-02804
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649797
• UDI-Public: 50382903649797
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

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: 04/30/2019
• Device Catalogue Number: 364979
• Device Lot Number: 7097784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other