MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER; URINOMETER, MECHANICAL

Model Number 158101310190

Device Problem Occlusion Within Device (1423)

Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Retention (2119)

Event Date 04/01/2014

Event Type  Injury  

Event Description

It was reported the unometer safeti plus was connected to the patient's foley catheter when the patient arrived in the intensive care unit.The nurse reportedly noticed the patient's abdomen was 'very large', the patient complained of pain and 'having consistent urinary urgency.' further examination found, only thirty-five milliliters of urine had drained into the unometer safety plus.Initially, the nurse attempted to drain urine by repositioning the drainage tube.No additional urine resulted.An ultrasound was performed and the patient was noted to have 857 milliliters of urine in their bladder.The nurse manually irrigated the foley catheter and disconnected it from the unometer safety plus.This resulted in urine draining 'very fast.' a 'fe' clots were noted at this time.When the foley catheter was reconnected to the unometer safeti plus, urine stopped draining.Again, the nurse disconnected the foley catheter from the unometer safeti plus and urine drained freely.The unometer safeti plus and foley catheter were reconnected and the unometer safeti plus was placed on the floor.Within ten minutes 800 milliliters of urine and waste had drained out from the patient.Finally, the nurse reports after two hours of use the initial unometer safeti plus was replaced with a new unometer safeti plus.Additional 245 milliliters of urine drained from the patient's bladder.No patient complications were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There was no reports of the patient being harmed as a result of this malfunction.Additional patient and event details have been requested.Should additional information become available, a follow-up report will be submitted.

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4490289
• MDR Text Key: 5496957
• Report Number: 3007966929-2015-00023
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158101310190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2015
• 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
• Treatment: QUFORA SILICONE FOLEY CATHETER
• Patient Outcome(s): Required Intervention