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

Catalog Number 364975

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

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.Lot #: unknown.Device manufacture date: unknown.Results: bd received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for foreign matter or mold on urine cups with the incident lot was not observed.Bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Conclusion: unconfirmed complaint.An absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customers¿ indicated failure mode.

Event Description

It was reported that there was an appearance of foreign matter or mold on 120 ml bd vacutainer® plastic urine collection cups.No serious injury, blood to mucous membrane exposure or medical intervention was reported.

Manufacturer Narrative

The initial mdr was submitted with the 510k number listed as k790366.It is corrected to read exempt.

• Brand Name: BD VACUTAINER® PLASTIC URINE COLLECTION CUP
• Type of Device: URINE COLLECTION CUP
• 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: 7075240
• MDR Text Key: 94208369
• Report Number: 1917413-2017-00204
• 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,Followup
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• 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