MAUDE Adverse Event Report: BECTON, DICKINSON & CO. 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP; URINE COLLECTION SYSTEM

Catalog Number 364975

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Date 04/04/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Results: two hundred sample cups were returned for evaluation.No defects were found in the cups.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: bd was not able to duplicate or confirm the customers indicated failure mode.

Event Description

It was reported that mold was found on a 120 ml bd vacutainer® plastic urine collection cup.No injury or medical intervention reported.

• Brand Name: 120 ML BD VACUTAINER® PLASTIC URINE COLLECTION CUP
• Type of Device: URINE COLLECTION SYSTEM
• 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: 7059070
• MDR Text Key: 93477997
• Report Number: 1917413-2017-00210
• Device Sequence Number: 1
• Product Code: KDT
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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