MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE STANDARD COLD PACK; PACK, HOT OR COLD, DISPOSABLE

Lot Number RA19196CAN

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Explosion (4006)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

Event Type  malfunction  

Event Description

Patient had a medline standard cold pack on abdomen.Mother noticed gray/brownish liquid on the wash cloth that the cold pack was resting on and immediately alerted rn.Rn immediately removed cold pack and soiled linens.Ensured no contents leaked onto patient's skin.Noticed tiny pin-like hole where cold pack contents were leaking; alerted charge nurse, nurse manager and other staff about potential issue with item.Suggestion to check integrity of all heat/cold packs before patient use.Rn noted in safety event reporting system report that similar incident occurred day before when after activated by nurse, product exploded on nurse, wall and floor.

• Brand Name: MEDLINE STANDARD COLD PACK
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9823754
• MDR Text Key: 183115377
• Report Number: 9823754
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: RA19196CAN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 3650 DA