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

Model Number 420669

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  

Manufacturer Narrative

Complainant state/province: (b)(6).Patient country: (b)(6).Contact office address: (b)(4).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: (b)(4), manufacturing site: (b)(4).

Event Description

It was reported that primary package was not sealed.The product was not used.Photographs depicting the issue were received from the complainant.

Manufacturer Narrative

(b)(6).Contact office address: (b)(4).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.(b)(4).

Event Description

It was reported that primary package was not sealed.The product was not used.Photographs depicting the issue were received from the complainant.

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 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 9l02664 was manufactured on 11/24/2019, 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 1704503 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) surgical cover dressing (scd)¿.The applicable quality tests performed to these batches based on the process instructions for assembly and primary packaging - surgical cover dressing (scd), 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) (refer to attachment 2).In addition, dimensional and seal test were performed with satisfactory results and documented in anexo 2 of procedure instruction (pi) (refer to attachment 2).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.

Event Description

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

• 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: 13024473
• MDR Text Key: 286060292
• Report Number: 9618003-2021-02762
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2021
• Device Model Number: 420669
• Device Lot Number: 9L02664
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/24/2019
• 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