MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES, INC. I.V. START KIT

Model Number	267004
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in this event is not available for evaluation.The complaint component part number (b)(4) (transpore tape) is manufactured by nanjing 3h medical products co., ltd.(fda registration 3007607706).A follow-up report will be provided upon conclusion of investigation and response by the component manufacturer.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
Customer states transpore tape did not adhere to the patient's skin, causing bleeding, catheter migration, and associated complications.The catheter was not secured entirely, site had to divert to a nonsterile tape to resolve, and there was some bleeding indicative of irritation or catheter issue per customer incident details.The issue was resolved by using a cartridge transport container which caused mild contamination.On (b)(6) 2025, the customer stated the adhesive tape doesn¿t have as good adhesion as other kits purchased before, therefore, it is difficult to have a proper fitting or securing of the iv catheter.As a solution, the medical treatment was to use another iv kit.The delay in procedure was approximately 15 minutes.
Additional Manufacturer Narrative
Supplier performed test on the retention sample which confirmed product adhesion met specification requirement.Based on the device history record review, there were no nonconformances during production of the complaint lot.Medical action industries is the convenience kit manufacturer; each production lot is inspected to ensure correct tape has been allocated per the bill of materials.No processes performed during knitting would contribute to this complaint.A twelve-month review shows four past complaints with three different issues, one for this same issue of not sticking for a different tape lot.This product lot shipped to various customers with no additional reports for issue on the complaint lot.Supplier feedback indicates customers should wait for the skin to completely dry after using alcohol and chlorhexidine for disinfection before applying the tape.This product incident is documented in the complaint database 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: I.V. START KIT
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES, INC.; 25 heywood rd.; arden NC 28704
• Manufacturer (Section G): NANJING 3H MEDICAL PRODUCTS CO.,LTD.; no.1, no.5, zhushan road; gaochun economic development zone; nanjing jiangsu, cn
• Manufacturer Contact: nichole coggins ; 25 heywood rd.; arden, NC 28704 ; 8287820529
• MDR Report Key: 21967173
• Report Number: 1030451-2025-00003
• Device Sequence Number: 18173490
• Product Code: LRS
• UDI-Device Identifier: 20809160004965
• UDI-Public: 20809160004965
• Combination Product (Y/N): N
• 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): 06/26/2025

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: 267004
• Device Catalogue Number: 267004
• Device Lot Number: 324996
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown