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

Catalog Number 990687

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/27/2018

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 before use of bd vacutainer® urinalysis preservative urine tube, 5 units had a sterility breach.

Event Description

It was reported that before use of bd vacutainer® urinalysis preservative urine tube, 5 units had a sterility breach.

Manufacturer Narrative

Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample sent by the customer was verified and it was possible observe packaging seal opened ¿ setup ¿ top web duplicated.The potential cause for the problem is an operational failure during top web setup at packaging machine.The operators will be notified from this complaint.The defect identified from this complaint will be monitored for trend evaluation.

• 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: 8255863
• MDR Text Key: 133336334
• Report Number: 3003916417-2018-00387
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 990687
• Device Lot Number: 8289539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Date Manufacturer Received: 12/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other