MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; STICKRIGHT, 4" X 2 YD

Catalog Number	MSC4224EPH
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026 the patient "required additional procedure to restart new epidural line" due to "tape that failed to adhere line to skin." per the customer, a "painful second procedure [was] needed to adequately control labor pain.".
Additional Manufacturer Narrative
It was reported that on (b)(6) 2026 the patient "required additional procedure to restart new epidural line" due to "tape that failed to adhere line to skin." per the customer, a "painful second procedure [was] needed to adequately control labor pain." it has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.Additional initial reporter information: mobile telephone number: (b)(6).

• Brand Name: MEDLINE
• Common Device Name: STICKRIGHT, 4" X 2 YD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25377257
• Report Number: 1417592-2026-02040
• Device Sequence Number: 15822389
• Product Code: KGX
• UDI-Device Identifier: 10197344102778
• UDI-Public: 10197344102778
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MSC4224EPH
• Device Lot Number: 87525110036
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female