MAUDE Adverse Event Report: UNOMEDICAL SDN BHD, BAKAR ARANG INDUSTRIAL ESTATE 2-WAY, HARD VALVE, STANDARD TIP, 30CC, CH18; CATHETER, RETENTION TYPE, BALLOON

Model Number MM41151830

Device Problem Difficult to Open or Remove Packaging Material (2922)

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

Event Date 07/23/2015

Event Type  malfunction  

Manufacturer Narrative

Based on the available info, this event is deemed to be a reportable malfunction.There were no reports of any pt harm as the device was not used on a pt.This fda 3500a form represents an unk number of devices that were reported for this complaint.No further info was available at the time of the report.Should add'l info become available, a f/u report will be submitted.There are two (2) cases associated with this complaint; therefore, a separate fda form 3500a has been generated to address the case.Reported to fda on (b)(6) 2015.

Event Description

It was reported and depicted by photo that the location indicated to open the foley catheter packaging does not work properly.The packaging requires "more strength to open and the package tears in the wrong place".

• Brand Name: 2-WAY, HARD VALVE, STANDARD TIP, 30CC, CH18
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNOMEDICAL SDN BHD, BAKAR ARANG INDUSTRIAL ESTATE; sungai petani, kedah 08000 ; MY 08000
• Manufacturer Contact: matthew walenciak, assoc, dir ; 211 american ave. ; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5004117
• MDR Text Key: 23562841
• Report Number: 9611710-2015-00153
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K954752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MM41151830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• 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