MAUDE Adverse Event Report: EPIC MEDICAL PTE LTD MCKESSON BRANDS; PUMP, ELASTOMERIC 270MLX10ML/HR

Catalog Number	16-EP27010
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that patients are having issues with getting drug to infuse when an extension set is attached to their picc line.No information was received regarding any serious injuries as a result of this product issue.

• Brand Name: MCKESSON BRANDS
• Common Device Name: PUMP, ELASTOMERIC 270MLX10ML/HR
• Manufacturer (Section D): EPIC MEDICAL PTE LTD; 500/73 m2 tambon tasit amphur; pluakdaeng wha e. sb ind. est; rayong, 21140 ; TH 21140
• MDR Report Key: 22575324
• Report Number: 1451040-2025-00050
• Device Sequence Number: 9457685
• Product Code: MEB
• UDI-Device Identifier: 10612479271521
• UDI-Public: 10612479271521
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025
• Report Date (Section F): 07/23/2025

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: 16-EP27010
• Device Lot Number: S24L086 AND S24L095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/07/2025
• Device Age: 12 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown