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

Model Number 420623

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

Device 2 of 2.E1: complainant city: (b)(6).Complainant country: united kingdom.Name of affiliation: wirral community health & care nhs foundation trust.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 two packets of company's dressing in a box of ten were not properly sealed, as they were not heat sealed at the top of inner packaging.The product was not used.A photograph depicting the issue was received from the complainant.

Manufacturer Narrative

A batch record review was completed and no discrepancies were found.All peelback sample tests completed throughout the batch manufacture at 15-minute intervals were satisfactory.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.Aquacel foam adh 21x21(1x5) eur was manufactured under sap code 1703945 and manufacturing lot number 3c00888 on 04 march 2023.Lot # 3c00888 was sterilized under work order (b)(4) and released on review of results of sterilization provided by sterilization company sterigenics.All of the results were within specification and products were released.No nonconformity was identified during the manufacturing process of lot 3c00888.This is the only complaint for the affected lot registered within database.Two photographs were received for this issue and have been evaluated in accordance with work instructions (wi).The photographs confirm the expected lot number, product and the complaint issue where an open seal is evident on a single primary sachet.A corrective action / preventive actions (capa) was opened for this complaint issue, which covered this batch and an additional batch 2k03366 received as part of an internal defect report received.Both batches have been investigated for open seals as part of this corrective action / preventive actions (capa) and investigation identified likely root cause was a material jam for the 2k03366 aspect of the corrective action / preventive actions (capa) and start up rejects or reclaim error for the 3c00888 aspect of the complaint.Regardless of root cause, both defects have likely been missed through manual inspection of the products at the end of the line before packaging.Part of this issue was a possible reflection of staffing levels and behavioral aspect.Historic evidence from previous complaint confirms the defect identified in 2k03366 has been seen before and was therefore a recurrent issue with multiple potential root causes.It was not possible to replicate the failure mode identified in batch 3c00888.The issue seen with this batch can occur as part to the machine startup process where initially non-sealed sachets are rejected, but it was possible for rejected samples to be reclaimed or replaced back onto the line by an operator.Corrections identified by the investigation include review and update of troubleshooting, inspection and staff levels, checking mechanical guides between process instruction (pi) and human machine interface (hmi) recipe, seal the base of the primary reject bin on optima line, additional signage at knife station to alert engineer of noise or missed cuts, one point lesson to escalate issues at knife station, check alignment of encoder disk at knife station, review training for knife replacement and alignment and check feasibility/add pause tooling onto optima line.A stop ship record was raised for batch 3c00888 and 2k03366 from internal reporting and both have been placed on stop due to products being available in dcs and have the potential risk of open seals and further complaints.Product from 3c00888 available in a uk dc (united kingdom distribution center) and product from 2k03366 on hold in china dc (distribution center) has been returned for reinspection and rework.A record for the rework order was raised and reinspection for portions of both affected batches was required to allow for stop ship disposition to be made.A health hazard evaluation was raised for both batches due to the open seals.This health hazard evaluation (hhe) was cancelled following an analysis of bounding as part of the investigation.All dressings processed on optima line over a period of 5 years to may 2023 resulted in a quantity of (b)(4) dressings (5 years based on shelf life of the product concerned).Zero complaints were received for the same icc code over the past 5 years (excluding complaint in question), therefore this complaint in question is the only complaint in past 5 years for this icc code.1 nonconformance was raised in production for open seal on the optima over the past 5 years for all parts produced (41.8m).There were 2 complaints for the other 4 related icc codes on the optima line for products using the same packaging pack size program (i.E.All 20x20 and 21x21 dressings, qty:(b)(4): 1.07cpm.Corrective action / preventive actions (capa) has identified a number of possible root causes.This additional information and supporting information support the closure of the health hazard evaluation (hhe) record.Corrective actions relating to inspection in production have resulted in three one point lessons being raised w/c 17th july 2023 for distribution across all shifts for signing are now complete.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

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

• 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: 17369444
• MDR Text Key: 320257149
• Report Number: 1000317571-2023-00173
• 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,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 420623
• Device Lot Number: 3C00888
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2023
• 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