FDA Adverse Event
Malfunction
Summary report: N
MCKESSON BRANDS
MDR report key: 22575324
·
Received July 23, 2025
Report
- Report Number
- 1451040-2025-00050
- Event Type
- Malfunction
- Date Received
- July 23, 2025
- Date of Event
- July 7, 2025
- Report Date
- July 23, 2025
- Manufacturer
- EPIC MEDICAL PTE LTD
- Product Code
- MEB
- UDI-DI
- 10612479271521
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1869941 | MCKESSON BRANDS | PUMP, ELASTOMERIC 270MLX10ML/HR | MEB | EPIC MEDICAL PTE LTD | S24L086 AND S24L095 | 10612479271521 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |