MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS; DRESSING,WOUND,HYDROPHILIC

Model Number 420669

Device Problem Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: (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.

Event Description

It was reported ¿the dressing was unable to be opened in theatre prior to applying it to the patient.¿ this occurred three times with the same lot number.It was stated that "the paper tears when trying to open them making them impossible to then open.¿ photos were received from the complainant depicting the reported issue.

Manufacturer Narrative

(b)(6).Returned sample evaluation: photo related to the reported problem is available for evaluation.Investigation summary: type- 2, wnd-pmc9.11 primary pack tears, rips or sheds material during opening (sterile products).On 22/mar/2021 a query was run by complaint investigator id5173 from 01/jan/2019 up to 22/mar/2021 in trackwise 8.7 system, associated to malfunction wnd-pmc9.11 primary pack tears, rips or sheds material during opening (sterile products) and one (1) complaint was identified.Unable to open the dressing packet in theatre prior to applying it to the patient.See below photo related to the reported problem: supporting information attached (type yes or no): yes attachment number attachment name personnel notification evidence.What is the extend of the nc? this document has been created to perform the preliminary investigation for complaints, lot number, icc and sap material for affected lot number 0g02559 with malfunction wnd-pmc9.11 primary pack tears, rips or sheds material during opening (sterile products), with severity rating 1.Is supporting information attached (type yes or no): yes.The scope of this nonconformance report is to cover the all products from scd manufacturing line.The following figure#1 shows complaints reported related to malfunction code ost-pmc7.14 from 01/jan/2019 up to 22/mar/2021.Batch records review: batch records review was performed by complaint investigator id5173 for the affected lots number 8g02559.A total of one (1) lots number were verified to confirm if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented the batch record review supports that there were no discrepancies related to the issue reported.Process description: load the dressing finished in the pouch ----> seal the pouch in the sealer bar -------> inspect the loaded pouches and stack them in trays in the rack -----> transport the rack to area of packing.History data review: query was run in trackwise system by complaint investigator id5173 since 01/jan/2019 up to 22/mar/2021, to determine a trend of failure mode wnd-pmc9.11 primary pack tears, rips or sheds material during opening (sterile products), one (1) complaint were identified and will be cover in this investigation.Non-nonconformance report was identified in two (2) years period.No scar have been generated to supplier regarding to the reported problem.Capa plan tw#1435453 and approved on 02/feb/2020 has been identified related to the reported problem and actions associated with this failure mode.Risk analysis: the actual severity of the complaints reported is 4.No harm reported.The complaint as described has been reviewed and does not represent a threat to public safety and therefore does not warrant a 5-day or 30-day report to the fda per 21 cfr part 803.In addition, there is no violation to any regulatory requirement, therefore, there is no risk to continued business and regulatory compliance.Conslusion: based on the results of the preliminary investigation, no harm was reported from any of the complainant, photo is available for evaluation, no samples are available for testing.Based on the evaluated photo, complaint reported have been confirmed.Nevertheless, no additional action is required, due to, no trend have been identified according to the preliminary investigation.Batch record review do not show nonconformance related to the manufacturing and packaging process.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.

Event Description

To date no additional patient or event details have been received.

• Brand Name: AQUACEL/AQUACEL AG - SURGICAL COVER DRESSINGS
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal
• MDR Report Key: 8290244
• MDR Text Key: 134515034
• Report Number: 9618003-2019-00861
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2020
• Device Model Number: 420669
• Device Lot Number: 8G02559
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1