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

Model Number 158100140190

Device Problems Biofilm coating in Device (1062); Collapse (1099); Obstruction of Flow (2423); Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

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

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

Height: 160 cm.Expiration date (08/2020).Manufacturing date (09/2015).Based on the available information, this event is deemed a reportable malfunction.No patient harm was reported.Additional information has been requested but not received to date.When additional information becomes available, a follow-up report will be submitted.Reported to the fda on: october 11, 2016.(b)(4).

Event Description

Complainant reporting that the patient was admitted to the icu with multiple complications."on (b)(6), the patient is catheterized and further the catheter is connected to a unometer.On (b)(6), the nurse identified obstruction at the sampling port during a urine sampling.The tubing of the system collapsed after they tried to vacuum it.As well, sediment or biofilm was observed in the sampling port." no further details have been provided.

Manufacturer Narrative

Device history records were reviewed.No non-conformance was initiated.Sterilization was performed in accordance with parameters.The batch was released according to requirements.A batch record review indicates no discrepancies initiated during production.The batch record review resulted in a discrepancy which was investigated in another complaint and is closed.No additional investigation is needed.A photograph has been received for this complaint, which was evaluated.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 november 03, 2016.(b)(4).

• Brand Name: UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER
• 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 voblast 22275 0; BO 222750
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 6017804
• MDR Text Key: 57103649
• Report Number: 3007966929-2016-00092
• 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
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• 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: 211912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2016
• 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
• Treatment: MEDICATIONS: AB TAZOBACTAM, MEROPENEM, LINEZOLID
• Patient Age: 58 YR
• Patient Weight: 60