FDA Adverse Event
Injury
Summary report: N
TRANSFER DEVICE ASEPTIC
MDR report key: 23705593
·
Received December 3, 2025
Report
- Report Number
- MW5179806
- Event Type
- Injury
- Date Received
- December 3, 2025
- Date of Event
- June 18, 2025
- Report Date
- June 20, 2025
- Manufacturer
- EQUASHIELD LLC.
- Product Code
- ONB
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- KY, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
REPORT: (B)(4): LLT CODES: 10069327: PRODUCT QUALITY ISSUE I NARRATIVE: PRODUCT QUALITY CONCERN. EQUASHIELD LUER LOCK ADAPTOR 2. LOT: 2528619A. EXP: 03/01/2028. PORT ADAPTER NOT CONNECTED - FALLING OUT. MAKES DEVICE UNUSABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2808039 | TRANSFER DEVICE ASEPTIC | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM | ONB | EQUASHIELD LLC. | 2528619A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Male |