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

Catalog Number 364975

Device Problem Component Missing (2306)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 10/15/2015

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Results: a sample was not returned for evaluation.A review of the device history record could not be performed as a lot number was not provided for this incident.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

Event Description

It was reported that the yellow tag was not on the lot of 120 ml bd vacutainer® plastic urine collection cup.The finger of the lab technician went inside the lid and was stuck by the needle.Evaluated for blood borne pathogens.

• 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: 7007590
• MDR Text Key: 91266105
• Report Number: 1917413-2017-00351
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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