MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES IV START KIT

Model Number	79094D
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Incident one of two.The product involved in the event was not returned for evaluation.A follow-up report will be provided upon conclusion of investigation.Medical action industries is the manufacturer of the piv start convenience kit containing the complaint medichoice skin protectant prep pad component, r6384, lot: 2410jk510a, manufactured by jianerkang medical co.Ltd.(fda registration 9616874).This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
Incident one.It was reported two patients had a reaction (described as burn) following use of skin prep component contained within piv start convenience kit.Patients are being monitored for any signs of infection.No other treatment or patient effects were communicated.
Additional Manufacturer Narrative
No samples available; the photograph confirms the reaction to r6384 component.The component is received pre-packaged and placed directly into kits.No on-site activities involve handling or altering the component in a way that could affect patient sensitivity or trigger reactions to its ingredients.There were no nonconformances reported during kit manufacturing.Based on review of the picture, the reaction seems to only be present where the dressing was applied.The root cause could not be definitively determined.This is the only complaint related to a reaction for this component received in 2025.The component is also used in other convenience kits.In 2024, there was only one similar complaint, which involved a different convenience kit and a different component lot.Hence there is no trend for this issue.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.

• Brand Name: IV START KIT
• Common Device Name: IV START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): JIANERKANG MEDICAL CO., LTD.; no.1, jianerkang road; zhixi town industrial zone jintan district; changzhou city jiangsu, china
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 22561040
• Report Number: 1030451-2025-00005
• Device Sequence Number: 18587975
• Product Code: LRS
• UDI-Device Identifier: 20809160410605
• UDI-Public: 20809160410605
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 79094D
• Device Catalogue Number: 79094D
• Device Lot Number: 328983
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown