MAUDE Adverse Event Report: SECUREMENTS; TAPE AND BANFDAGE ADHESIVE

Model Number 670M

Device Problems Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922)

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.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.

Event Description

The distributor reported that the anesthesia assistant found it difficult to open the uno epi-fix securement device packages without contamination of the device.It was reported that in approximately 50% of the devices in the box, the peel back paper does not open neatly at the seams, but instead rips on the paper side, which creates issues in trying to introduce the product into the sterile field.The devices were not used on the patients.A photograph was provided, which depicted the package ripping while difficult to open.No further information has been made available.

Manufacturer Narrative

Received an unused product sample, depicting the reported event of the product being torn during opening based on visual inspection.Investigation is in process at this time.No additional patient/event details have been received or 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 BANFDAGE ADHESIVE
• MDR Report Key: 6754068
• MDR Text Key: 81411574
• Report Number: 1000317571-2017-00039
• 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
• 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: 07/31/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 10/24/2017
• 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