MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 PORTED 12X9CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number	66004009
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	05/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, mild erythema was observed around the catheter orifice due to allergy; the same iv3000 ported 12x9cm ctn 50 was changed, resulting in improvement after medical treatment with oral antibiotics and topical cream.The procedure was resumed after a significant surgical delay using a s+n back-up device and no injury was reported as a consequence of this issue.
Additional Manufacturer Narrative
H11: internal complaint reference (b)(4).H3, h6: this complaint was opened by smith+nephew to document a product problem associated with a smith+nephew device.The reported problem relates to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H11: given the nature of the alleged incident, the product, could not be returned for evaluation.The review of the production records showed no manufacturing issues that could have contributed to the reported incident.A review of complaint history based on the historical data revealed a similar previous event; this adverse event will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this adverse event was previously identified.The anticipated risk level is still adequate.A historical review concluded that there have been no previous escalated actions for the part number and adverse event reported.A factor that could contribute to the reported event include an adverse skin reaction to the product materials, such as the adhesive.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Internal complaint reference: case-2025-00267447-1.
Additional Manufacturer Narrative
Internal complaint reference: case-(b)(4) additional information: b1: type of report, b2: outcomes attributed to adverse event, h1: type of reportable event h11:given the nature of the alleged incident, the product, could not be returned for evaluation.The clinical/medical investigation concluded that based on the limited information provided, a definitive clinical root cause of the reported ¿mild erythema¿ could not be determined.Although we cannot rule out the iv3000 dressing as a possible contributing factor to the reported mild erythema based on its placement and improvement following its removal.It is unclear if the instructions for use for iv3000 was adhered to.As the instructions for use does precautions, ¿as with all adhesive products, apply and remove carefully from sensitive or fragile skin.If reddening or sensitization occurs, discontinue use.¿ the report stated the same iv3000 ported was changed, resulting in improvement following treatment medically with oral antibiotics and topical cream.It was reported the procedure was completed after a significant delay, with an s&n back-up device injury as a result of this consequence.The impact to the patient beyond the mild erythema, oral antibiotics, topical cream and the significant delay could not be determined since the since the patient¿s outcome was not provided.The review of the production records showed no manufacturing issues that could have contributed to the reported incident.A review of complaint history based on the historical data revealed a similar previous event; this adverse event will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this adverse event was previously identified.The anticipated risk level is still adequate.A historical review concluded that there have been no previous escalated actions for the part number and adverse event reported.The instructions for use document revealed in the section precautions.As stated in the clinical investigation, that if reddening or sensitization occurs, discontinue use.A factor that could contribute to the reported event include an adverse skin reaction to the product materials, such as the adhesive.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: IV3000 PORTED 12X9CM CTN 50
• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22204695
• Report Number: 8043484-2025-00064
• Device Sequence Number: 12484575
• Product Code: KGX
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 66004009
• Device Lot Number: 2424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2025
• Supplement Date Received by Manufacturer: 07/11/2025; 06/05/2026
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/17/2025; 06/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female