MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Catalog Number 59410082

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  Injury  

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.A complaints history review was carried out using the lot and part numbers provided, there have been further complaints reported with this failure mode in the past three years.The devices were used for treatment.The returned samples were evaluated.A visual inspection did not identify creasing on any of the returned dressings.There are checks in place to prevent creasing of the film.If creasing is identified during in-process checks, it is tabbed and recorded in the fault log.A functional evaluation found delamination on the dressings.Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process.During the manufacturing of the dressing, in process checks are undertaken for this product.All material is manufactured according to the specification and only product meeting the release criteria will be passed on for further processing.A clinical investigation concluded, ¿per product evaluation, delamination was noted on all six sample dressings; however, no creasing issues were identified.The root cause of the skin reaction is not able to be concluded but the shipping/ handling/ storage variances beyond smith and nephew control could be contributing factors to the reported findings.Reportedly, competitor product was applied and no patient injury resulted.The patient¿s status was reported as ¿normal¿ therefore no further impact is anticipated.No further medical assessment is warranted at this time.¿ a risk management review found that the risk files for this product contains local infection, systemic infection and phlebitis as harms related to creased film.The ifu and carton labelling was reviewed.No information was found that could have contributed to the reported issue.We were not able to confirm a relationship between the device and the reported creasing / curled edges or the reported reaction.The root cause of the reported creased film and subsequent adverse reaction remains undetermined.Delamination is due to the manufacturing process.As delamination is a low occurring issue no further actions are deemed necessary.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.

Event Description

It was reported that during s+n investigation, the iv3000 dressing was found to present delamination.No patient was involved.Treatment was completed using a backup from another company.

• Brand Name: IV3000 WINDOW FRAME 6X7CM CTN 100
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 4407940038
• MDR Report Key: 10135464
• MDR Text Key: 194549383
• Report Number: 8043484-2020-00676
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 59410082
• Device Lot Number: 1809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2020
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention