MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PACK,HOT,INSTANT,LRG,6X9"

Catalog Number	MDS139009
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hot pack containing sodium acetate ruptured during use, resulting in a crystallized substance found on the patient's forearm following a peripheral iv insertion.
Additional Manufacturer Narrative
It was reported that an rn was using hot pack to dilate the patient's veins prior to initiating a peripheral iv (piv).At the time the warm pack was being used, there was no obvious evidence of a solution leak onto the patient's hand.The rn then used an antiseptic wipe immediately prior to angiocath insertion.Following a successful piv insertion and application of a transparent dressing, a crystallized substance approximately 1 cm in diameter was noted on the patient's anterior forearm.Further inspection identified a splotch on the coban wrap, and it was subsequently determined that a significant amount of solution had leaked from the warm pack onto the underpad on the side tray and onto the floor.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.

• Brand Name: MEDLINE
• Common Device Name: PACK,HOT,INSTANT,LRG,6X9"
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sara young ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50902356
• Report Number: 1417592-2026-10420
• Device Sequence Number: 13452419
• Product Code: IMD
• UDI-Device Identifier: 10888277320550
• UDI-Public: 10888277320550
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Device Catalogue Number: MDS139009
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• 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