MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, MEDIUM, 6X6.5IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11450-040B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/1980
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record review was completed on the reported lot number (v1k125).The review revealed the product was manufactured and released to predetermined specifications on 8/16/21.No anomalies were found during review of the records.No sample was received for investigation; therefore, we were unable to determined a root cause.However, we are taking the following actions: first, process for all hot lines were updated to ensure preventative maintenance is occurring at the proper frequency.Second, a warning label is being added to the label that specifies that ¿when activating, hold away from patient.¿ we will continue to monitor complaint trends.
Event or Problem Description
The customer reported a hot pack that was being utilized prior to an iv insertion burst and the inner contents leaked out of the packaging and did reach the patient.There was no concern or harm for the patient.No demographics or other information provided.Report being filed for risk to staff member and patient.

• Brand Name: HOT PACK, MEDIUM, 6X6.5IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 12694493
• Report Number: 1423537-2021-00684
• Device Sequence Number: 3973442
• Product Code: IMD
• UDI-Device Identifier: 10885380167188
• UDI-Public: 10885380167188
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 11450-040B
• Device Catalogue Number: 11450-040B
• Device Lot Number: V1K125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/25/2021
• Patient Sequence Number: 1