FDA Adverse Event
Malfunction
Summary report: N
MEDLINE EZ TEAR CLEAR SPECIMEN TRANSPORT BAG WITH ABSORBENT PAD
MDR report key: 23178686
·
Received September 30, 2025
Report
- Report Number
- 23178686
- Event Type
- Malfunction
- Date Received
- September 30, 2025
- Date of Event
- April 16, 2025
- Report Date
- September 5, 2025
- Manufacturer
- MEDLINE INDUSTRIES INC
- Product Code
- NNK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
I AM TOLD THAT THE CURRENT BIOHAZARD BAGS LEAK. WE FILL THEM WITH ICE FOR MANY TESTS TO SEND TO THE LAB, AND APPARENTLY IF THE BAGS ARE NOT SITTING PERFECTLY UPRIGHT WHEN FILLED WITH ICE, THEY LEAK ALL OVER THE CARTS WITH THE LAPTOPS ON THEM. WHILE THE PHLEBOTOMIST IS GLOVED, ALSO TRYING TO LABEL ALL THEIR SAMPLES NOW WITH NO DRY WORK SURFACE. THIS ALSO CONCERNS ME AS WE SOMETIMES RECEIVE A LEAKY URINE IN A BAG THOUGH THE TUBE SYSTEM, CAN THIS BE AN INFECTION CONTROL ISSUE? I AM TOLD IT IS COMING FROM THE PERFORATION AT THE TOP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2104966 | MEDLINE EZ TEAR CLEAR SPECIMEN TRANSPORT BAG WITH ABSORBENT PAD | CONTAINER, SPECIMEN MAILER AND STORAGE, NON-STERILE | NNK | MEDLINE INDUSTRIES INC | DYND269ABS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |