MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI+, 110CM,2L,RH; URINE FLOW RATE MEASURING

Model Number 158100510190

Device Problem Disconnection (1171)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There were no reports of the patient or healthcare providers being harmed as a result of this malfunction.No additional information was available at the time of the report.Should additional information become available, a follow-up report will be submitted.Reported to the fda on september 01, 2015 (b)(4).

Event Description

It was reported that within 24 hours of use on a patient in the intensive care unit, the "entire anti-kink and inlet tubing part was easily disconnected from the top of the urine chamber, spilling the patient's urine onto the nurse and doctor nearby".There were no reports of infection or complications.Also, a depiction of the complaint issue was provided by photograph.

Manufacturer Narrative

Additional information was received on september 23, 2015.A quality investigation was performed on september 22, 2015.After a detailed batch review no discrepancies (includes non-conformance/deviation) related to complaint was found.A non-conformance was opened.This complaint will remain open until the completion of the non-conformance.Correction: evaluation method code was not added to the initial mdr submitted september 01, 2015.Manufacturer report number 3007966929-2015-00078.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on october 2, 2015.(b)(4).

• Brand Name: UNOMETER SAFETI+, 110CM,2L,RH
• Type of Device: URINE FLOW RATE MEASURING
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street; 50 fanipol dzerzhinsk district; minsk region, minskaya voblast 22275 0; BO 222750
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5048591
• MDR Text Key: 24761414
• Report Number: 3007966929-2015-00078
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Reporter Occupation: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Model Number: 158100510190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1