MAUDE Adverse Event Report: UNOMEDICAL S.R.O. URINARY DRAINAGE BAGS; BAG, URINARYM ILEOSTOMY, 78EXH

Model Number 38 162 1S-20

Device Problems Blocked Connection (2888); Connection Problem (2900)

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

Event Date 06/19/2014

Event Type  malfunction  

Event Description

It was reported "the tube which must be inserted in the plastic holder comes off from his own compartment blocking the passage of urine".Note: issue occurred on (2) separate cases.A separate 3500a form has been completed for the other (1) case.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.Add'l info was requested on (b)(4), (b)(4) and (b)(4)2014.Add'l info received via email dated: (b)(4)2014 in response to the question: can we inquire as to if the blockage or urine is from the tube leading away from the catheter or blocking the drainage of urine from the top measuring device to the bag below? response: "the blockage or urine is from the tube leading away from the catheter".To date no add'l info has been received.Should add'l info become available, a follow up report will be submitted.

• Brand Name: URINARY DRAINAGE BAGS
• Type of Device: BAG, URINARYM ILEOSTOMY, 78EXH
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer Contact: matthew walenciak, interim associ ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4177489
• MDR Text Key: 5089887
• Report Number: 3005778470-2014-00050
• Device Sequence Number: 1
• Product Code: EXH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: 38 162 1S-20
• Device Catalogue Number: 38 162 1S-20
• Device Lot Number: 494028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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