MAUDE Adverse Event Report: CONVATEC LTD SECUREMENTS; TAPE AND BANDAGE, ADHESIVE

Model Number 680M

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).

Event Description

It was reported that foreign matter in the package.The product was not used on or by a patient.A photograph depicting the reported complaint issue was provided by the complainant.

Manufacturer Narrative

A batch record review indicates no discrepancies.Machine logs have been checked and no discrepancies were found.Preventive maintenance (pm) logs have been checked and all pm's were completed.Lot # 6l04316 was sterilized and released on review of results of sterilization.All the results were within specification and products were released.The production process, in process testing and packaging of products were run in accordance with process instructions for machine multivac.A visual inspection was performed in accordance with test methods and was completed at the beginning of the order and every hour following until the order was completed.A photograph has been received and has been evaluated in accordance with work instructions.The photograph confirms the complaint issue but does not confirm the lot number.This product is no longer manufactured in (b)(4) and is now manufactured in (b)(4).This issue will be monitored through the post market product monitoring review.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

Event Description

To date no additional patient or event details has been received.

• Brand Name: SECUREMENTS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: jeanette johnson ; 7900 triad center drive; suite 400; greensboro, NC 27409 ; 3365424681
• MDR Report Key: 8582863
• MDR Text Key: 144155104
• Report Number: 1000317571-2019-00047
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 11/01/2019
• Device Model Number: 680M
• Device Lot Number: 6L04316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1