MAUDE Adverse Event Report: TBD; TAPE AND BANDAGE

Model Number 502306

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

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Brand name is: uno epi-fix (25/250) ster int.Initial reporter complainant state/ province is: (b)(6).Based on the available information, this event is deemed a product malfunction.No patient harm was reported.Additional details have been requested but not provided to date.Should additional information become available, a follow up report will be submitted.(b)(4).

Event Description

It was reported that "the product cannot be unpacked sterile because the "back" of the product breaks - the paper breaks." photograph provided depicting the reported complaint issue.No further information was available.

Manufacturer Narrative

Updated brand name: uno epi-fix (25/250)ster int.Updated mfr contact info: from na to no.Updated explant date: procode.Updated pma#: exempt.Corrected device evaluated by mfr?: from na to no.Updated device manufacture date: 12/07/2016.Batch records have been reviewed; all required specification was met and documented within the batch records.There were no discrepancies noted in the batch record related to the reported complaint issue.Machine logs were reviewed and no issues were identified relating to the complaint.All pm's (preventive maintenance) were completed to schedule.A photograph was received; however the complaint issue cannot be determined.No return product available to identify root cause.No risk as product can still be used.A record was opened previously for this issue on the multivac line, this has been closed.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: TBD
• Type of Device: TAPE AND BANDAGE
• MDR Report Key: 6323830
• MDR Text Key: 67482170
• Report Number: 1000317571-2017-00009
• 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

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: 502306
• Device Lot Number: 6L06428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/16/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1