MAUDE Adverse Event Report: UNOMEDICAL LTD UNOMETER SAFETI PLUS - WITH LUER-LOCK; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number 413454

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Expiration date: 08/2020.Manufacturer date: 09/2015.Based on the available information, this event is deemed a reportable malfunction, no patient harm was reported.A batch record review indicated that there were no discrepancies related to complaint issue.Although it did result in a previous discrepancy which was investigated and is now closed.On the base of information received, the investigation concluded that the true root cause for the issue "loss of physical integrity of unometer safeti plus product" cannot be identified.No corrective actions are required at the moment.No additional investigation is needed, this issue will be monitored through the post market product monitoring review process.If additional information becomes available, a follow-up report will be submitted.(b)(4).

Event Description

Complaint received reporting that the catheter connector was broken when the package was opened.No further information was available.

Manufacturer Narrative

Corrected data: this information was omitted on the initial mdr submission on september 23, 2016 with mfr report# 3007966929-2016-00078.The device history records were reviewed.Sterilization was performed in accordance with parameters.The batch was released according to requirements.Additionally, it was noted that several photos were provided by the reporter regarding the reported event.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 17, 2016.(b)(4).

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK
• Type of Device: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): UNOMEDICAL LTD; zavodskaya street, 50; fanipol dzerzhinsk district; minsk region, minskaya voblasts 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5972891
• MDR Text Key: 55452197
• Report Number: 3007966929-2016-00078
• Device Sequence Number: 1
• Product Code: FFG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413454
• Device Lot Number: 212960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2016
• 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: Unknown
• Patient Sequence Number: 1