MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAGS; COLLECTOR, URINE, (AND ACCESSORIES)

Model Number 30 017 0 - LIPA

Device Problem Connection Problem (2900)

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

Event Date 06/21/2013

Event Type  malfunction  

Event Description

It was reported "the connection tube got off the urine bag completely during catheterization.".

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It was further reported no lot number is available and on the urine bag are two figures "10, 12" graved.Additional information was received via email on (b)(4) 2014 informing the product was used by the patient; defect was noticed during use; patient required no medical treatment; event did not result in any serious injury, hospitalization, disability, permanent injury or death to patient; patient's medical health was reported as good; event occurred during catheterization and no information provided on whether the device was removed or discontinued.A quality evaluation was performed on (b)(4) 2014.Received and evaluated was on contaminated sample.The reported failure was confirmed by visual inspection.The sample did not meet the requirements.Lot number has not been provided by customer therefore device history records of manufacturing process cannot be check and investigation process has been performed based on the history records of product reference code and failure in mention.No increasing trend associated with product reference code and failure in mention has been registered within last 24 months.Root cause analysis showed that the defect was probably occurred during the interruption of machine cycle during production process at the machine.Based on the information received and investigation findings this failure is considered to be isolated with low occurrence.No further corrective action is required.The failure is included in relevant risk management file and associated hazard is evaluated there.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 (b)(4), 2014.

• Brand Name: URINARY DRAINAGE BAGS
• Type of Device: COLLECTOR, URINE, (AND ACCESSORIES)
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, int.assoc.dir. ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3921505
• MDR Text Key: 4519446
• Report Number: 3005778470-2014-00035
• Device Sequence Number: 1
• Product Code: KNX
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30 017 0 - LIPA
• Device Catalogue Number: 30 017 0 - LIPA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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