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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE
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SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Model Number 66024007
Medical Device Problem Code Nonstandard Device (1420)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/25/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that 40 iv3000 1 hand 6x7cm ctn 100 of lot 2012 were turned back to distributor for many dressings were empty and curled.No case involved.
 
Additional Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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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 Key11979888
Report Number8043484-2021-01433
Device Sequence Number19921779
Product Code KGX
UDI-Device Identifier05000223417383
UDI-Public05000223417383
Combination Product (Y/N)N
Initial Reporter CountryCH
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/21/2021
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 Number66024007
Device Catalogue Number4007
Device Lot Number2012
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 05/26/2021
Supplement Date Received by Manufacturer05/26/2021
Initial Report FDA Received Date06/10/2021
Supplement Report FDA Received Date06/21/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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