MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE

Model Number	66024007
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number case: (b)(4).
Event or Problem Description
It was reported that in a iv3000 1 hand 6x7cm ctn 100 box the back liner was separated from the film.This problem was present in multiple dressings from the same box.No case involved.No patient involvement.
Additional Manufacturer Narrative
H3, h6: 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 complaint history review, was performed for the product and event description, there have been a number of further instances reported.It was reported that in a iv3000 1 hand 6x7cm ctn 100 box the film layer which is coated with adhesive was missing, leaving the dressings free within the pack.This problem was present in multiple dressings from the same box.No case involved.No patient involvement.The device was not being used in treatment or diagnosis.Several samples from the same batch/lot, which were intended for use, were evaluated which confirmed a relationship between the event and the device.Investigation revealed that at a certain point in manufacture, the film layer, rather than passing around one of the rollers, adhered to the roller and the machine stopped.The coating of this roller was changed to one with a lower adhesive setting so that the adhesive on the film would not stick to it.The operators were not aware that when they started the machine up again, that the dressings would not be automatically rejected, so a small number of dressings completed the process without the film layer.In order to prevent reoccurrence, an instruction was given to the operators, to send these dressings to waste manually, until all dressings with no film has passed the reject gate area.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: IV3000 1 HAND 6X7CM CTN 100
• Common Device Name: 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
• MDR Report Key: 12096703
• Report Number: 8043484-2021-01626
• Device Sequence Number: 3975807
• Product Code: KGX
• UDI-Device Identifier: 05000223417383
• UDI-Public: 05000223417383
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 66024007
• Device Catalogue Number: 4007
• Device Lot Number: 2012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1