MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES KIT: IV 100/CS

Model Number	267004
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not available for evaluation.Medical action industries is the manufacturer of the iv kit containing transparent tape, r4966 (lots 25063h26a, 25093h26a).The lots manufactured in the complaint convenience kit lot was sourced from supplier, nanjing 3h medical products co.,ltd.(3007607706).The complaint details were forwarded to the appropriate functional group for investigation and root cause analysis.Based on the review and testing of the retained samples, nanjing 3h medical products co., ltd.Was unable to confirm the reported product failure.Retained samples were evaluated for viscosity and met all established specifications.An evaluation of the device history record for the reported lot confirmed that the product was manufactured according to specifications, with no nonconformances identified during production.No upward trend has been observed for this type of issue.As a result, a definitive root cause could not be determined, and no further actions will be taken.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
Staff reported that the tape was not adhering well to patients, creating concern that the iv could migrate or become dislodged.Additional tape was required to maintain secure placement.She recalled only a few occurrences, none of which warranted a patient safety alert.When asked whether patients might have had lotion or other substances on their skin that could affect adhesion, the site acknowledged that this was possible.At this time, staff indicated that there is insufficient information to pursue further action, and the concern can be closed.

• Brand Name: KIT: IV 100/CS
• Common Device Name: KIT: IV 100/CS
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES; 25 heywood road; arden NC 28704
• Manufacturer (Section G): NANJING 3H MEDICAL PRODUCTS CO.,LTD.; no.1, no.5, zhushan road; gaochun economic development zone; nanjing, jiangsu 21130 0; CH 211300
• Manufacturer Contact: nichole coggins ; 25 heywood road; arden, NC 28704 ; 8287820529
• MDR Report Key: 25385065
• Report Number: 1030451-2026-00027
• Device Sequence Number: 13349118
• Product Code: LRS
• UDI-Device Identifier: 20809160004965
• UDI-Public: 20809160004965
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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 Number: 267004
• Device Catalogue Number: 267004
• Device Lot Number: 342027
• 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: 05/15/2026
• Initial Report FDA Received Date: 06/03/2026
• 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
• Patient Sex: Unknown