MAUDE Adverse Event Report: SECUREMENTS; TAPE AND BANDAGE ADHESIVE

Model Number 670M

Device Problem Difficult to Open or Remove Packaging Material (2922)

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.A batch record review indicates no discrepancies.Preventative maintenance was completed to schedule.Machine logs were reviewed and there were no issues relating to the complaint.This issue will be monitored through the post market product monitoring review process.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

A general complaint was received for an unknown number of devices all from the same lot number.The hospital warehouse employee reported that ¿the sterile packaging cannot be opened without ripping the paper.The glue of the packaging seems so strong that it is difficult to open the product sterile in one go.¿ it was further reported that the customer tried multiple pieces of same lot number, but the ¿paper rips every time and packaging does not open correctly.¿ the number of packages impacted was reported as unknown.There was no reported patient harm.No photographs were provided.

• Brand Name: SECUREMENTS
• Type of Device: TAPE AND BANDAGE ADHESIVE
• MDR Report Key: 7215487
• MDR Text Key: 98297770
• Report Number: 1000317571-2018-00007
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: 670M
• Device Lot Number: 6J00453
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1