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

Model Number 158101310190

Device Problem Decoupling (1145)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2014

Event Type  malfunction  

Event Description

It was reported the unometer double lumen tube became disconnected from the chamber.No patient consequences were reported as a result of this event.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.There are two additional cases with similar disconnection problems manufactured under two different lots.Additional mdr reports will be submitted for each case.No additional patient/event details have been provided to date.Should additional information become available, a follow-up report will be submitted.

Manufacturer Narrative

The following information was received.The device history record was reviewed and there were no related non-conformance report concerning the complaint issue.Complaints were analyzed and no negative trend identified.A capa was initiated on the base of root cause investigation.The complaint lot was produced before implementation of capa.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

Manufacturer Narrative

Corrected data: a query was performed using the following parameters: date range of october 28, 2014 to april 15, 2015; brand name type: unometer 500-urinometer.The results of the query identified twelve (12) reported complaints for this reported complaint issue- loss of physical integrity.Eight (8) were identified as being associated with reference number (b)(4).There were seven (7) complaints for the malfunction code inlet tubing detaches from the connector or drainage bag/urine measurement chamber, leakage may occur, six (6) were identified as being associated with reference number (b)(4).Manufacturer expiration date from 06/2018 to 06/01/2018.This was not documented on mdr manufacturer report number 3007966929-2014-00112.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 19, 2015.

• 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 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: 4344906
• MDR Text Key: 5139474
• Report Number: 3007966929-2014-00112
• Device Sequence Number: 1
• Product Code: EXR
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K896732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/10/2014

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 Expiration Date: 06/01/2018
• Device Model Number: 158101310190
• Device Lot Number: 654706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2013
• 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