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)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

(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: (b)(4).

Event Description

It was reported that on (b)(6) 2020, the dressing sleeve seam welding was missing on one side and the dressing was unsterile.The product was not used on patient.Photographs depicting the issue were received from the complainant.

Manufacturer Narrative

(b)(6).Batch record review: lot 9l02664 product name aquacel scd drs 9x30cm (1x10pk) eur, it¿s was manufactured on 11/24/2019, in the zone 2-handpack american line with a total of (b)(4) market units.Complaint investigator id 3687 performed a batch record review on 04/23/2021, to verify if all the applicable procedures were followed, under icc code 420669, sap material id 1704503 and manufacturing order 1479827.The batch record review supports that there were no discrepancies related to the issue reported.The bulk item record was reviewed for lot# 9l02663 item description dressing aquacel surg 9x30cm, sap material 1705049 and manufacturing order 1498631.It was manufactured on 11/24/2019.Manufacturing line scd assembly.The crew requirements and responsibilities, process parameters, quality and in-process inspections, line operations, process troubleshooting and relevant documents to the process were run according the process instructions pi31-097.The process requirements results were documented in the product batch records br31-097.Conclusion summary of the related event: based on the investigation findings, the root causes for the open seal primary packaging scd were identified as method and manpower, as: excess of wip in the packaging station (method): there is not a continuous flow from the rotary table to the packaging station, batches of dressings need to be manually moved from the rotary table to the packaging station.The pouch entry cycle time is 3 seconds and the pouch seal cycle time is 5 seconds, this creates a wip that can potentially cause confusion to operators during the sealing process.Procedure step not followed (manpower): the step 8.4.6 of pi31-097 ver 14.0 establishes that the pouches must be inspected before transporting them to the secondary packaging area and considering that the pouches with open seal reported by the supplier had not been sealed.There has been found a potential deviation in the compliance of the procedure among all operators involved in the sealing process.In addition, is established by pi31-104 ver 7.0 ¿ process instructions for manual packaging of scd (secondary packaging), that the primary packages are visually inspected during the generation of the first piece, every hour and continuously during the packaging process as per tm-002 method 7.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
• MDR Report Key: 11009943
• MDR Text Key: 221494839
• Report Number: 9618003-2020-15475
• 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,other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1