MAUDE Adverse Event Report: UNOMEDICAL SDN BHD 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.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".

Manufacturer Narrative

Additional information received: a quality investigation was performed.No sample was returned for evaluation.A batch record review found no discrepancies and revealed the packaging processes were operating within the established parameters.Although a picture of the product was provided, there was not enough information to conclude the product did not meet specifications or perform as intended.Further, a root cause of the reported issue could not be determined.No similar/previous investigations for this issue were available.Product monitoring reviews will monitor product trends if this issue were to reoccur.No further actions are required, and the complaint will be closed.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Manufacturer Narrative

Additional information was received on (b)(6) 2015 from the complaint engineer of manufacturing site: updated sections expiration date and device manufacture date due to new information.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.

• Brand Name: 2-WAY, HARD VALVE, STANDARD TIP, 30CC, CH18
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNOMEDICAL SDN BHD ; bakar industrial estate; sungai petani, kedah 08000 ; MY 08000
• Manufacturer (Section G): CONVATEC; 211 american ave; greensboro NC 27409
• Manufacturer Contact: matthew walenciak ; 211 american ave; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 5004118
• MDR Text Key: 23562994
• Report Number: 9611710-2015-00152
• 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 Expiration Date: 09/01/2018
• Device Model Number: MM41151830
• Device Lot Number: 545198R001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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