MAUDE Adverse Event Report: BARD MEDICAL MIDSTREAM URINE COLLECTION KIT; URINE COLLECTION KIT (EXCLUDES HIV TESTING)

Catalog Number 842904

Device Problems Leak/Splash (1354); Device Slipped (1584); Device Contamination With Biological Material (2908)

Patient Problem No Information (3190)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Urine specimen container in cath kit is unable to tolerate being sent by the pneumatic tube system without frequent leakage due to cap loosening.Purchasing has been working on this, but has been unable to obtain an improved product.When cap loosens, specimen contents are spilled inside the pneumatic tube shuttle, creating a bio hazard exposure and requiring another specimen to be obtained from the patient.

• Brand Name: MIDSTREAM URINE COLLECTION KIT
• Type of Device: URINE COLLECTION KIT (EXCLUDES HIV TESTING)
• Manufacturer (Section D): BARD MEDICAL; 13183 harland dr; covington GA 30014
• MDR Report Key: 3969951
• MDR Text Key: 4606657
• Report Number: 3969951
• Device Sequence Number: 1
• Product Code: OIE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 842904
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1