MAUDE Adverse Event Report: CONVATEC LTD AQUACEL FOAM; Dressing, wound, hydrophilic

Model Number 422625

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

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

Event Type  malfunction  

Manufacturer Narrative

Common device name: dressing,wound,hydrophilic.Product code: nac.Complainant street address: (b)(6).Complainant city: (b)(6).Complainant postal code: (b)(6).Name of affiliation : (b)(6).Complainant country: (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 Description

It was reported by the pharmacy technician to the company representative that there was a foreign substance within the product which appears to be hair based on the received photograph.The product was not used by patient.Earlier the affected quantity was not confirmed but later, it was confirmed by another employee of the pharmacy of the hospital that company's sales representative has possession of all affected dressings and the sales representative confirmed that only three dressings would be concerned.A photograph depicting the issue was received from the complainant.

Event Description

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

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.A batch record review was completed, and no discrepancies were found.Aquacel foam nadh 12.5x12.5cm 1x10pk eur was manufactured under system application product (sap) code 1729904 and lot number 2c04132 manufactured on 29/03/2022.Lot # 2c04132 was sterilized and released on review of results of sterilization provided by sterilization company sterigenics.All results were within specification and products were released.No nonconformity was registered during the manufacturing process of lot 2c04132.This is the only complaint for the affected lot registered within database.Photographs and complaint samples were requested on 14 oct 2022 upon receipt of the complaint to identify the foreign matter.One photograph was received on 03 nov 2022 and has been evaluated in accordance with work instruction (wi).The photograph confirms the expected lot number product and complaint issue where a foreign matter (hair) can be seen within the primary sachet.The original samples requested on 14 oct 2022 were not received before the 30-day medical device reporting (mdr) deadline for this complaint.The complaint does have a valid lot number.This complaint will be processes as a type 2 investigation complaint with no physical sample.Should a sample be received for the complaint, the case will be reopened and investigated with physical sample.As no samples have been received for this issue no non-conformances (nc) could be raised to investigate.Upon identification of the foreign matter being a hair on 03 nov 2022, it was confirmed two other complaints have been received within the last two months for hairs identified in sachets.The products impacted across the three complaints have been manufactured on the same manufacturing line, and non-conformances are open for both complaints.Investigation was opened and identified personal protective equipment (ppe) is suitable for use in the controlled environment, but there is the potential for transfer onto garments and product, or to enter on products from suppliers.Regular good manufacturing practice (gmp) audits are conducted in the controlled environments, and the procedures for good manufacturing practice (gmp) and gowning procedure for entry into the controlled environment will be reinforced.The relating investigation continues, but the findings are not expected to be different for this investigation.No further investigation is necessary for this issue unless the samples requested are received.This issue will be monitored through the post market product monitoring review process, standard operating procedure (sop).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: 1000317571.

• Brand Name: AQUACEL FOAM
• Type of Device: Dressing, wound, hydrophilic
• Manufacturer (Section D): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer (Section G): CONVATEC LTD; first avenue; deeside industrial park; deeside, flintshire CH5 2 NU; UK CH5 2NU
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15742288
• MDR Text Key: 307597156
• Report Number: 1000317571-2022-00341
• Device Sequence Number: 1
• Product Code: NAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 422625
• Device Lot Number: 2C04132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2022
• 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