MAUDE Adverse Event Report: BD; URINE COLLECTOR

Catalog Number 364957

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/26/2015

Event Type  malfunction  

Event Description

Rn attempting to open clean catch urine container, pressed too hard causing puncture wound to left thumb.

• Type of Device: URINE COLLECTOR
• Manufacturer (Section D): BD; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 5056516
• MDR Text Key: 25008763
• Report Number: 5056516
• Device Sequence Number: 1
• Product Code: NNW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: 364957
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other