MAUDE Adverse Event Report: AERO-MED, LTD. AERO-MED URINE COLLECTION KIT; BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)

Catalog Number AMM568

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Event Description

Employee was transferring urines, using the urine transfer cup.She went to put the red and yellow top tube onto the exposed needle portion of the cup, and the needle part got stuck inside the tube.The device has been discarded.No patient/employee harm.

• Brand Name: AERO-MED URINE COLLECTION KIT
• Type of Device: BLOOD AND URINE COLLECTION KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): AERO-MED, LTD.; 5110 west 74th street; building 97; indianapolis IN 46268
• MDR Report Key: 7613839
• MDR Text Key: 111498655
• Report Number: 7613839
• Device Sequence Number: 1
• Product Code: OIB
• 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
• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AMM568
• Other Device ID Number: 8362474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/06/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/06/2018
• 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