MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; WARMER,HEEL,INFANT,GEL PK,100CS

Catalog Number	MDS138007
Medical Device Problem Codes	Fluid/Blood Leak (1250); Premature Activation (1484); Sharp Edges (4013)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "it appears as something from the inside punctured through when the nurse was kneading the pack." "pouch appeared to have a tiny pin prick in the bag upon inspection following the injury.".
Additional Manufacturer Narrative
The customer reported that the pouch "didn¿t seem filled with air like it normally is" and when they went to squeeze the pouch to mix up the contents, they felt a sharp pain in the left pinky finger and were bleeding; the injury looked like a pin prick, a bandaid was applied, and no serious injury, medical intervention, or follow-up care was required.Medline received one infant heel warmer in used condition in a hazard bag; the bag was wet from the inner contents, there was no visible cuts or damage to the outer bag, the inner contents of the bag were crystalized as if they were pre-activated, and some of the crystalized inner contents felt sharp through the bag.The customer complaint has been confirmed.It is most likely that the heel warmer was pre-activated and crystalized prior to the customer trying to activate it; no cuts or rips were found in the outer package to explain the inner liquid leaking out, and the division will monitor through trending.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.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: WARMER,HEEL,INFANT,GEL PK,100CS
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50695652
• Report Number: 1417592-2026-35103
• Device Sequence Number: 18545400
• Product Code: MPO
• UDI-Device Identifier: 40080196719656
• UDI-Public: 40080196719656
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/04/2026

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: MDS138007
• Device Lot Number: VN23243A17
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown