MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® URINE COLLECTION CUP

Catalog Number 364941

Device Problem Leak/Splash (1354)

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

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the cannulas on bd vacutainer® urine collections cups were found missing which could lead to potential leakage.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.However, further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Investigation conclusion: although no samples or photos were available for evaluation, bd has initiated further investigation through a capa.The capa has identified the most likely root causes and corrective actions are in the process of being implemented.Based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue.The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUP
• Type of Device: URINE COLLECTION CUP
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• MDR Report Key: 7627146
• MDR Text Key: 112311511
• Report Number: 9617032-2018-00319
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 364941
• Device Lot Number: 7342787
• Date Manufacturer Received: 05/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other