MAUDE Adverse Event Report: AQUACEL AG+EXT 20X30CM (1X5PK); DRESSING, WOUND, DRUG

Model Number	413569
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.Additional information was requested but, no additional information has been provided to date.Should additional information become available a follow-up report will be submitted.(b)(4).
Event or Problem Description
It was reported the product was not sealed and part of the dressing was hanging out of the primary packet.Photos of the reported device complaint were provided by the complainant.
Additional Manufacturer Narrative
This complaint has been evaluated.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.The production monitoring system was reviewed and the seals were cleaned, there were pad splice jams and registration problems during the manufacture of the batch which may impact the complaint issue.All preventative maintenance was completed to schedule.Machine logs show fitters were on-line to repair registration issues at the time of manufacture.Photograph provided confirms evidence of seal issues.This complaint issue is associated with a previous site investigation.The site investigation, has been closed.A root cause investigation was opened and is now closed.The root cause investigation found that a buildup of debris and glue on sealing system to be the most probable cause for this issue.There is currently a revalidation program across all machines at the manufacturing plant.No additional information is available at this time.Should additional information become available, a follow-up report will be submitted.(b)(4).

• Brand Name: AQUACEL AG+EXT 20X30CM (1X5PK)
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 6301149
• Report Number: 1000317571-2017-00003
• Device Sequence Number: 1518171
• Product Code: FRO
• UDI-Device Identifier: 00768455132041
• UDI-Public: 768455132041
• Combination Product (Y/N): N
• PMA/510(K) Number: K152926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial 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
• Operator of Device: Other
• Device Expiration Date: 05/01/2018
• Device Model Number: 413569
• Device Catalogue Number: 413569
• Device Lot Number: 6E03274
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: 12/19/2017
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1