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 6 of 6 e1: complainant city: (b)(6) complainant country: (b)(6) name of hospital: (b)(6) trust based on the available information, this event is deemed to be a reportable malfunction.Returned sample evaluation: photos associated with this case were received for evaluation.Batch record review: lot 3e00390 was manufactured on 5/9/2023, in scd (surgical cover dressing) packaging line, with a total of 960 market units.The complaint investigator performed a batch record review on 24/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 id 1704503 and manufacturing order 1679130.The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are no photographs associated with this case.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 (capa) identified will be taken through capa record in database.The investigation associated with related event record has been approved and was 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.

Event Description

It was reported that the heat sealing of the inner packaging of dressing was not sealed in six dressings out of ten in a box.The product was not used on patient.No photographs depicting the issue were received.

• 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: 18289711
• MDR Text Key: 329997390
• Report Number: 9618003-2023-15317
• 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
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• 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?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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