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

Catalog Number 364975

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/15/2015

Event Type  malfunction  

Manufacturer Narrative

Results- a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion- without a sample, an absolute root cause for this incident cannot be determined.

Event Description

It was reported that a lab tech received a sample in a bd vacutainer plastic urine collection cup.The device's lid was wrapped with parafilm to prevent leaking and the protective cover on the needle was not in place.As the tech was trying to remove the lid from the cup, the index finger of his left hand went inside the lid receptacle and he stuck himself on the needle.He was evaluated for bloodborne pathogens.The source patient was seeing an infectious disease doctor for (b)(6).

• Brand Name: BD VACUTAINER® PLASTIC URINE COLLECTION CUP WITH INTEGRATED SAMPLING DEVICE
• Type of Device: 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: 5210728
• MDR Text Key: 31082938
• Report Number: 1917413-2015-00001
• Device Sequence Number: 1
• Product Code: OIE
• 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: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 364975
• Device Lot Number: UNKNOWN
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other