MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL SURGICAL; DRESSING,WOUND,HYDROPHILIC

Model Number 420669

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Device 1 of 2 e1: complainant city: tilburg complainant country: netherlands name of affiliation: etz tilburg 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 reporting site: 1049092 manufacturing site: 9618003.

Event Description

The nurse reported that there was no seal layer in package and so the package was not sterile.The product was not used by the patient.A photograph depicting the issue was received from the complainant.

Event Description

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

Manufacturer Narrative

Additional information - this emdr is being submitted to include the below: h6: investigation results under imdrf cause investigation code, imdrf investigation findings, imdrf cause conclusions h10: investigation summary batch record review: lot 3e00390 was manufactured 09 may 2023, in scd (surgical cover dressing) packaging line, with a total of (b)(4) market units (mkus).Compliance engineer performed a batch record review on 10 nov 2023, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material identification (id) 1704503 and manufacturing order (b)(4).Therefore, no discrepancy related to this issue were found within the documentation.Photograph, video and/or physical sample evaluation: there is a photograph associated with this case and in it, the reported defect can be observed.No unused return sample was expected.Conclusion summary of the related event: based on the revision of the observation of the processes involved, interviews to the personnel of the line and the expertise of the triage team, this failure mode was attributed to the following probable causes: method: the machine does not have a method for avoid performing the operation on out of the validated process ranges for temperature.Corrective and preventive actions identified will be taken through corrective action / preventive actions (capa) plan.The investigation associated with related event has been approved and is complete.No additional action is required, and this complaint will be closed.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.Fda registration number reporting site: 1049092 manufacturing site: 9618003.

• Brand Name: AQUACEL SURGICAL
• Type of Device: DRESSING,WOUND,HYDROPHILIC
• Manufacturer (Section D): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer (Section G): CONVATEC DOMINICAN REPUBLIC INC; km 18.5 parque industrial; itabo, s.a. haina; san cristobal 91000 ; DR 91000
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 18090072
• MDR Text Key: 328410368
• Report Number: 9618003-2023-11552
• 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: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420669
• Device Lot Number: 3E00390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1