FDA Adverse Event
Other
Summary report: N
BD SMARTSITE EXTENSION SET
MDR report key: 17595339
·
Received August 21, 2023
Report
- Report Number
- MW5144819
- Event Type
- Other
- Date Received
- August 21, 2023
- Report Date
- June 14, 2023
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- FPA
- Report Source
- Voluntary report
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
AMIODARONE INFUSION CAN LEACH DEHP FROM THE ADMINISTRATION SET AND CAUSE IT TO BE INFUSED INTO THE PATIENT. DEHP MAY BE A CARCINOGEN. OUR STAFF MISUNDERSTOOD THE BD PACKAGING (SEE PICTURE) AND THOUGHT THAT THE EXTENSION SET WITH A FILTER DIDN'T CONTAIN DEHP. SEVERAL PHARMACY STAFF MEMBERS VOICED CONCERN THAT IT CONTAINED DEHP, ONLY TO BE REASSURED BY PHARMACISTS THAT IT DIDN'T. THE PHARMACISTS EXPLAINED THAT THE SYMBOLS ON THE PACKAGE WERE ONLY A GLOSSARY, AND THAT THIS DIDN'T MEAN THAT THERE WAS ACTUALLY DEHP IN THE TUBING. FINALLY, A NEW PHARMACIST WAS CHECKING AN AMIODARONE INFUSION, AND SPOKE UP TO SAY " I THINK THIS CONTAINS DEHP". A CALL TO THE MANUFACTURER CONFIRMED THAT IT DOES. (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1035636 | BD SMARTSITE EXTENSION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION 303, INC. | 20028E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | AMIODARONE INJECTION. |