MAUDE Adverse Event Report: CONVATEC LIMITED CONVATEC - ACCESSORIES - ANCHORING DEVICE; ACCESSORIES, CATHETER

Model Number 037449

Device Problems Device Disinfection Or Sterilization Issue (2909); Device Markings/Labelling Problem (2911)

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

Event Date 07/14/2014

Event Type  malfunction  

Event Description

Packaging unclear in as to whether the product is sterile on the inside or not.This resulted in contamination of a sterile field.

Manufacturer Narrative

Based on the available information, this event is deemed a reportable malfunction.It was further suggested by the complainant the product packaging needs to change to make clear that the product is unsterile.The product lot number was recorded as could not obtain, indicating no lot number was available.As no complaint sample was received, as assignable cause could not be determined.No evidence was found that product failed to meet all of the requirements and specifications at the time of manufacture.There are no additional complaints reported for this specific icc code.A review of the complaint listing for the previous twelve months for this product icc code indicates this was the only complaint registered for this icc code, date and complaint issue.Product met specification and no corrective actions will be raised as a result of this evaluation.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.Reported to the fda on (b)(4) 2014.

• Brand Name: CONVATEC - ACCESSORIES - ANCHORING DEVICE
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): CONVATEC LIMITED; unit 20, first avenue; deeside industrial park; deeside, flintshire CH5 2NU; UK CH5 2NU
• Manufacturer Contact: matthew walenciak, int. assoc.dir ; 211 american ave.; greensboro, NC 27409 ; 9083779293
• MDR Report Key: 4066622
• MDR Text Key: 20782876
• Report Number: 1000317571-2014-00061
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K932143
• 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: 07/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 037449
• Device Catalogue Number: 037449
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2014
• 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