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

Model Number 158100510190

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Urinary Retention (2119)

Event Date 07/01/2015

Event Type  Injury  

Event Description

The nurse reports scarce urine drainage from the patient even after doses of diuretics administered per medication schedule.It is further reported 'in the following hours 300 cubic centimeters' of urine was obtained and patient was diagnosed with urinary retention.The nurse adds on (b)(6), 2015 the following urine output from the patient was obtained: at eighteen hours 70cc, at twenty hours 30cc at which time 10 mg of furosemide was administered 'in accordance to the schedule', at twenty-two hours 35cc, at twenty-four hours 20cc.The nurse adds at 02 am on (b)(6) 2015 the patient had 90 cc urine output and received 10mg of furosemide 'as scheduled'.The urine output at 04 am on (b)(6) 2015 was 300cc, at 06 am 200cc and on the 'day shift of (b)(6) 2015 there are no variabilities reported in relation to the diuresis data'.The nurse adds the unometer safeti plus was in place for thirteen days.

Manufacturer Narrative

Based on the available information, this event is deemed to be a serious injury.No further information was available at the time of the report.Additional patient/event details have been requested.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

A quality complaint investigation was performed.A complaint sample was not received to assist with the investigation.After a detailed batch review, no discrepancies related to complaint issue were found.A previous investigation is applicable to this complaint.This previous investigation is closed.Therefore, this complaint will be closed without further action.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
• Type of Device: URINOMETER, MECHANICAL
• Manufacturer (Section D): UNOMEDICAL LTD.; zavodskaya street ; 50 fanipol dzerzhinsk district; minsk region, minskaya voblasts ; BO
• Manufacturer (Section G): CONVATEC; 211 american avenue; greensboro 27409
• Manufacturer Contact: matthew walenciak ; 211 american avenue; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4927651
• MDR Text Key: 21545874
• Report Number: 3007966929-2015-00064
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2018
• Device Model Number: 158100510190
• Device Lot Number: 654400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 95 YR