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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

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SMITH & NEPHEW MEDICAL LTD. IV3000 WINDOW FRAME 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 59410882
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2020
Event Type  malfunction  
Event Description
It was reported that when the customer removed the carrier#2 of the iv3000 dressing, the film dressing adhered to the carrier#2 and peeled off from the frame, so it was impossible to use.A backup was available.No delay was reported.
 
Manufacturer Narrative
We have now concluded our investigation into this complaint.The batch record was 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 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 device was intended for use in treatment.It was reported that issues were identified during application.The returned samples were visually and functionally evaluated which confirmed the failure mode of delamination.This confirmed a relationship between the event and the device.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.The root cause was determined as a manufacturing process issue.As this is failure mode¿s current occurrence rate is within our acceptable range, no further actions are deemed necessary.The relevant manufacturing team will be informed of this complaint.Smith and nephew acknowledges 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.
 
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Brand Name
IV3000 WINDOW FRAME 10X12CM CTN 50
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK  HU3 2BN
MDR Report Key10317466
MDR Text Key200191112
Report Number8043484-2020-02171
Device Sequence Number1
Product Code KGX
UDI-Device Identifier04582111151575
UDI-Public4582111151575
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/19/2020
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
Device Operator Health Professional
Device Catalogue Number59410882
Device Lot Number1848
Initial Date Manufacturer Received 06/30/2020
Initial Date FDA Received07/23/2020
Supplement Dates Manufacturer Received08/14/2020
Supplement Dates FDA Received08/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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