MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC L3W0600 - AQUACEL; DRESSING,WOUND,HYDROPHILIC

Model Number 412019

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

It was reported that part of the primary package was not crimped.The product was not used on patient.The photographs depicting the issue were received from the complainant.

Event Description

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

Manufacturer Narrative

H10: investigation summary d17 is selected under imdrf cause conclusion because the concluded cause is not adequately described by any other term for the machine not having a method for avoid performing the operation on out of the validated process ranges for temperature.Batch record review: lot 1j01511 was manufactured on 09/15/2021, in the surgical cover dressing (scd) line with a total of (b)(4) market units.Complaint investigator performed a batch record review on 03/10/2023, to verify if all the applicable procedures were followed system application product (sap) material identification 1257951 and manufacturing order (b)(4).As result no nonconformance was identified.Photo related to the reported problem is available for evaluation.Investigation conclusion: the purpose of this root cause investigation is the identify the probable cause for the complaint generated for surgical cover dressing (scd) 3 line due to ¿open seal (malfunction) scd¿.The applicable quality tests performed to these batches based on the process instructions (pi) for assembly and primary packaging - surgical cover dressing, obtained satisfactory results.All the components for assembly were correct per bill of materials (bom) and the machine parameters documented were also correct and documented in ¿anexo 1¿ of procedure instruction (pi).In addition, dimensional and seal test were performed with satisfactory results and documented in anexo 2 of procedure instruction (pi).No irregularities were found related to malfunction, nevertheless, as resulted on the section c) and d) is the probable cause of the issue since the equipment has no enabled alarms or others prevention systems for avoiding running the equipment with the validated parameters out of the process specification ranges as per procedure instruction (pi).-root cause (s).Method: the machine does not have a method for avoid performing the operation on out of the validated process ranges for temperature.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: L3W0600 - AQUACEL
• 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: 13973665
• MDR Text Key: 288372893
• Report Number: 9618003-2022-00294
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/01/2023
• Device Model Number: 412019
• Device Lot Number: 1J01511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/13/2023
• Date Device Manufactured: 09/15/2021
• 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