MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIFIX 15CMX10M CTN 1; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66000375

Device Problems Loss of or Failure to Bond (1068); Device Difficult to Setup or Prepare (1487)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2020

Event Type  malfunction  

Event Description

It was reported that the dressing is not sticky enough for being used.No harm or injury reported.

Manufacturer Narrative

H3, h6: the device, used in treatment, has not been returned for evaluation, nor a control sample.Due to this we cannot assess the individual product and are unable establish a relationship between the reported complaint and the device or determine a root cause on this occasion.The batch/lot number provided was not recognized, rendering a review of the device history not possible.However, at this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Complaint history for the reported event has been reviewed, revealing further instances.The wound contact surface is coated with a gentle silicone adhesive layer that ensures non-traumatic removal at dressing changes.The silicone adhesive will feel sticky when compared to an acrylic adhesive and is specially designed to be very soft and gentle, but can soften further, particularly at higher temperatures.This is an inherent characteristic of all of the silicone adhesives and gives them their soft / gentle properties.It is therefore possible if the product has been stored at a high temperature, this could have contributed to the reported issue.No further actions are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

Manufacturer Narrative

H10: reassessment of this incident found it not to fulfill reporting criteria.A device that is difficult to setup or prepare device would not be likely to cause or contribute to a death or serious injury.Event may result in minor or temporary injury (e.G., pain) requiring no or minor medical intervention.The event may require use of a backup device to continue therapy.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.This event is considered not reportable pursuant to 21 cfr §803.The device was used for treatment and was returned for analysis.The device showed no issues visually or functionally and adhered to the skin as expected.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed no similar instances in the last 12 months.A risk management review concluded that without further information the alleged failure cannot be directly linked to a specific failure mode within the risk file although it does contain several failure modes that can result in decreased adhesion.No change to the risk file is required.Probable root cause is that the device has been stored in the incorrect conditions and not in accordance with the ifu.The devices must be stored in the conditions outlined to prevent environmental factors such as temperature from affecting them.An increase in temperature above that recommended may affect the adhesive nature of the device, which can cause issues such as those described in the event.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device must be stored.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE FLEXIFIX 15CMX10M CTN 1
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly freestone ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 10224597
• MDR Text Key: 197326056
• Report Number: 8043484-2020-01336
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 05000223420765
• UDI-Public: 5000223420765
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66000375
• Device Lot Number: 2004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1