MAUDE Adverse Event Report: UNOMEDICAL SDN BHD SILICONE 2 WAY PAED 10X05 CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 907.421.0310

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Expiration date: 12/2020.Manufacturing date: 12/2015.Based on the available information, this event is deemed to be a reportable malfunction.Based on information provided, there is no patient harm in this case.After review of the returned unused product sample, a discrepancy was found.Visual examination found that the product inside the pouch was not corresponding with the product printed on the pouch label.This warrants further action and a non-conformance, has been opened.This complaint will remain open until completion of non-conformance.Note: this complaint issue is associated with nine (9) separate cases.A separate 3500a forms have been completed for the other cases.No additional details have been provided to date.Should additional information become available, a follow-up report will be submitted.Reported to the fda on april 14, 2016.(b)(4).

Event Description

It was reported that upon opening a 10fg pediatric foley silicone catheter, the staff noticed that it was a 14fg adult foley silicone catheter inside the packaging.The device was not used on a patient.

• Brand Name: SILICONE 2 WAY PAED 10X05 CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): UNOMEDICAL SDN BHD; bakar arang industrial estate; sungai petani, kedah, malaysia 08000 ; MY 08000
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 5579762
• MDR Text Key: 42754410
• Report Number: 9611710-2016-00042
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K954752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 907.421.0310
• Device Lot Number: 814930R002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2016
• Initial Date FDA Received: 04/14/2016
• 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