MAUDE Adverse Event Report: CONVATEC LTD AQUACEL RIBBON WSF; DRESSING, WOUND, HYDROPHILIC

Model Number 420127

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

E1: (b)(6).Based on the available information, this event is deemed to be a reportable malfunction.A batch record review was completed and no discrepancies were found.All seal integrity tests completed throughout the batch manufacture were satisfactory.Aquacel wsf 1x45cm ster(1x5pk)eur was manufactured under system application product (sap) code 1700178 and manufacturing lot number 3a01075 on 16 january 2023.Lot # 3a01075 was sterilized under run id 2173-34300a and released on review of results of sterilization provided by sterilization company steris.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3a01075.This is the only complaint for the affected lot registered within database.The batch was identified as having been under planned deviation, relating to the use of newly validated lippke burst testers to be used instead of cobham burst testers due to the higher accuracy.The cobham burst testers are pre-populated in some batch records, so the deviation is in place to allow documentation of the newly validated lippke testers.This deviation would not have caused open seals, so is unrelated.Two photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the product, lot and expected complaint issue where a single open sachet can be seen with a dressing in the seal.The open sachet contains a piece of ribbon dressing which is caught in the seal.A corrective action / preventive actions (capa) has been raised recently for an open seal identified on a batch produced on the same manufacturing line (universal line).The investigation identified that the flipper cylinder on the line slowed down as fibre was catching pusher on the upstroke.The sensor guides were not lined up and first fold position and symmetry by moving securing clamps holding the reed switches.The process instruction for the line did not give adequate instructions for the set up of the cylinder fold sensors.It was also identified that operators were not trained against the process instruction or the standards of acceptability.There have now been 3 complaints for dressing in seal from the universal manufacturing line (including this complaint), and it was not appropriate to raise a new corrective action / preventive actions (capa) while the corrective action / preventive actions (capa) already open still has open actions being implemented.Previously, complaints for this malfunction code and machine were zero.The implementation dates for the actions will be noted and any further complaints checked against those dates.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: 1000317571.

Event Description

It was reported by the distributor that one end of the rope was welded with the blister weld seam, user had to cut the product and rest remained in the blister.The product was used on patient.There was no harm reported.The photographs depicting the issue were received from the complainant.

• Brand Name: AQUACEL RIBBON WSF
• 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: 18391037
• MDR Text Key: 331300588
• Report Number: 1000317571-2023-00330
• 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
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420127
• Device Lot Number: 3A01075
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• 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