MAUDE Adverse Event Report: UNOMEDICAL LTD. UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER SLIP; DEVICE, URINE FLOW RATE MEASURING

Model Number 158100140190

Device Problems Biofilm coating in Device (1062); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Expiration date 05/2020.Manufacturing date 06/2015.Based on the available information, this event is deemed a reportable malfunction.Additional information has been requested but not received to date.When additional information becomes available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that a patient was admitted to the intensive care unit (icu) and required connection to a foley catheter and urine collection with the device.On (b)(6) 2016, healthcare professionals identified presence of biofilm and urinary sediment in the space between the catheter connector and the first non-return valve.Hematuria sediment on the walls of the measuring chamber was also noted.Therefore, the system was changed due to the elevated risk of urinary infection related to the catheter.No further information was provided including treatment or outcome.

Manufacturer Narrative

A batch record indicates that no non-conformances and deviations related to complaint issue were initiated.The batch record review resulted in a discrepancy which was investigated and has been closed.Sterilization was performed in accordance with parameters.The investigation concludes that the likely root cause for the issue "stop flow between patient and chamber of unometer product" cannot be identified on the basis of the information received.No corrective actions are required at the this time.No additional investigation is needed.It was reported that the device was used during 9 days.The recommended period of usage is 7 days.This issue will be monitored through the post market product monitoring review process.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 june 2, 2016.(b)(4).

Manufacturer Narrative

Supplemental submission for mfr report# 3007966929-2016-00037 on june 02, 2016.This report is to further clarify, that there was a discrepancy found during a previous associated investigation, which is closed.The batch record for this reported event did not reveal any discrepancies/deviations that were related to the complaint issue.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: UNOMETER SAFETI PLUS - WITH LUER-LOCK & LUER SLIP
• Type of Device: 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 Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5651705
• MDR Text Key: 45101165
• Report Number: 3007966929-2016-00037
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 158100140190
• Device Lot Number: 206060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2016
• 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
• Patient Age: 47 YR
• Patient Weight: 120