MAUDE Adverse Event Report: UNOMEDICAL S.R.O. OR/GASTRO/STOMACH; TUBE, FEEDING, 78FPD

Model Number 23038339

Device Problem Leak/Splash (1354)

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

Event Date 04/17/2014

Event Type  malfunction  

Event Description

It was reported the connection between catheter tube and the hub is leaky.

Manufacturer Narrative

Based on the available info, this event is deemed a reportable malfunction.It was further reported that the product was not used on the pt.No additional pt/event details have been provided to date.Should additional info becomes available a follow-up report will be submitted.Reported to the fda on 05/12/2014.

• Brand Name: OR/GASTRO/STOMACH
• Type of Device: TUBE, FEEDING, 78FPD
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3; michalovce 07101 ; LO 07101
• Manufacturer (Section G): S.R.O.
• Manufacturer Contact: matthew walenciak, assoc dir ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 3912404
• MDR Text Key: 4514405
• Report Number: 3005778470-2014-00021
• Device Sequence Number: 1
• Product Code: FPD
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23038339
• Device Catalogue Number: 23038339
• Device Lot Number: 498163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2014
• 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