MAUDE Adverse Event Report: AQUACEL EXTRA; DRESSING, WOUND, DRUG

Model Number	420676
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Based on the available information, this event is deemed to be a reportable malfunction.  to date no additional information has been received.Should additional information become available, a follow-up report will be submitted.  fda registration number :(b)(4).
Event or Problem Description
It was reported upon opening a 10x10cm aquacel ag extra dressing, the dressing seated in the packet was not correctly orientated and as a result appears to have been heat sealed in the packet rendering it unsterile.Photos depicting the reported complaint issue were provided by the complainant.
Additional Manufacturer Narrative
During a batch record review it was noted that reject gate jams were an issue whilst this batch was being manufactured.A site investigation was open but, is now closed.A photograph was received in relation to this complaint confirming the product/ lot information and the complaint issue.The potential root causes were found to be were found to be that at the time of manufacture the pad cutter blade was not changed on a regular basis.A corrective action/preventive action has been initiated to capture the cutter blade and frequency of change.Another potential root cause has been identified that skewing of the dressing after the inspection of the vision system could occur if the dressing has lifted at a corner the dressing could catch on the nip rollers and cause it to skew and be processed through the secondary pack process.Another potential root cause was that reject gate issue were identified during the manufacture of the complaint sachet however there are no documented recordings on which gate was affected and what was done to rectify the issue.No additional investigation is needed.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.

• Brand Name: AQUACEL EXTRA
• Common Device Name: DRESSING, WOUND, DRUG
• MDR Report Key: 7130753
• Report Number: 1000317571-2017-00075
• Device Sequence Number: 11271999
• Product Code: FRO
• UDI-Device Identifier: 00768455127405
• UDI-Public: 768455127405
• Combination Product (Y/N): N
• PMA/510(K) Number: K121275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• 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: 06/01/2020
• Device Model Number: 420676
• Device Catalogue Number: 420676
• Device Lot Number: 7F02682
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/08/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1