MAUDE Adverse Event Report: CONVATEC DOMINICAN REPUBLIC INC AQUACEL AG+/AAA SURGICAL; DRESSING, WOUND, DRUG

Model Number	422606
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The emdr is being submitted for five company¿s dressings from one market unit with unsealed packaging causing the product to fall out of the secondary packaging.It was reported by a representative from surgical suite to the company¿s sales representative that when they went to use the dressing, after opening the package from the end with the arrow, the dressing fell out from the opposite end due to the packaging not being heat sealed properly at the other end.The product was not used on patient.The photographs depicting the issue were obtained by company¿s sales representative and sent to company's product manager.
Additional Manufacturer Narrative
Device 2 of 5.Common device name: dressing, wound, drug.Name of the affiliation: (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.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
To date no additional patient or event details have been received.
Additional 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: 2g00896 was manufactured on 07/18/2022, 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: 1728533 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¿.During the batch record review process for affected lot: 2g00895 manufactured in surgical cover dressing (scd), order no.(b)(4) and system application product (sap) code: 1728501, it was identified that these batches had no deviations, nonconformities, corrections, or corrective/preventative action (capa) within the quality system (database).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: AQUACEL AG+/AAA SURGICAL
• Common Device Name: DRESSING, WOUND, DRUG
• 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: 16270218
• Report Number: 9618003-2023-00206
• Device Sequence Number: 6082727
• Product Code: FRO
• UDI-Device Identifier: 00768455169559
• UDI-Public: 00768455169559
• Combination Product (Y/N): N
• PMA/510(K) Number: K091034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/01/2024
• Device Model Number: 422606
• Device Catalogue Number: 422606
• Device Lot Number: 2G00896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 03/13/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown