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

Model Number 680M

Device Problems Loss of or Failure to Bond (1068); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Additional patient/event details have been requested but none have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

Event Description

The healthcare provider reported that, ¿the glue is not secure and the fixation is falling apart, then the catheter is exponated [exposed].This results in that way that the catheter is not fixed.¿ there was no harm to the patient.No photograph depicting the reported issue was provided.Although requested, no additional information was provided.

Manufacturer Narrative

A batch record review indicates no discrepancies.Batch record review was conducted resulting in the following: the production process, in-process control, testing result, sterilization, visual inspection, and packaging of products showed that all the results were within specification and products were released.Photograph and samples has not been received for this complaint.Review of the device history review (dhr) showed that all relevant tests required during the manufacturing process, packaging process and final product release had been fulfilled and met the requirements.No nonconformity has been registered during the manufacturing process of the mentioned lot.No another complaint of this nature on the affected lot has been registered or received.This issue will be monitored through the post market product monitoring review process.No additional patient/event details have been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).

• Brand Name: SECUREMENTS
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• MDR Report Key: 7080226
• MDR Text Key: 94206793
• Report Number: 3005778470-2017-00020
• 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: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Model Number: 680M
• Device Lot Number: 7J00494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/14/2017
• Initial Date FDA Received: 12/04/2017
• Supplement Dates Manufacturer Received: 01/11/2018
• Supplement Dates FDA Received: 01/30/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1