FDA Adverse Event
Malfunction
Summary report: N
RHOPHYLAC
MDR report key: 1908935
·
Received November 18, 2010
Report
- Report Number
- MW5018299
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Report Date
- November 18, 2010
- Manufacturer
- CSL BEHRING
- Product Code
- FMF
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
RHOPHYLAC SYRINGES ARE PREFILLED IN A GLASS SYRINGE. WE HAVE HAD MULTIPLE OCCURRENCES OF THE SYRINGE BECOMING STOPPED UP AFTER ATTACHMENT TO A CLAVE NEEDLELESS IV ADAPTER. I HAVE PERSONALLY SENT THE PRODUCT BACK TO THE MANUFACTURER DEMANDING AN ANSWER TO THE PROBLEM. I NOW HAVE A LETTER FROM THE MANUFACTURER THAT A PORTION OF THE CLAVE BREAKS OFF IN THE SYRINGE BLOCKING THE FLUID PATH RENDERING THE SYRINGE USELESS. THE COMPANY REPRESENTATIVE IN EARLY DISCUSSIONS TOLD ME "WE MANUFACTURE PRODUCTS FOR WORLDWIDE USE AND CANNOT REFORMULATE THE SYRINGE DUE TO PROBLEMS WITH YOUR CLAVE. THE CLAVE IS AN OUTDATED PRODUCT ANYWAY." DATES OF USE: (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RHOPHYLAC | NONE | FMF | CSL BEHRING |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |