FDA Adverse Event
Other
Summary report: N
PRIMARY IV SET
MDR report key: 23771734
·
Received December 10, 2025
Report
- Report Number
- MW5180290
- Event Type
- Other
- Date Received
- December 10, 2025
- Manufacturer
- BECTON DICKINSON AND COMPANY
- Product Code
- FPA
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
TODAY A PRIMARY IV SET CAME APART BELOW THE PLASTIC SLIDE CLAMP. MATERIALS IS AWARE AND THE MEDLINE REP IS IN HOUSE TODAY. THIS HAPPENED YESTERDAY WITH A BLOOD TUBING SET. BOTH ARE BD. POOR PRODUCT SEWING: (I. E. VIAL, SYRINGE, BAG) MANUFACTURER PRODUCT QUALITY ISSUE. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2554717 | PRIMARY IV SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON DICKINSON AND COMPANY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |