FDA Adverse Event
Malfunction
Summary report: N
12 CC CONTROL SYRINGE
MDR report key: 1190663
·
Received October 2, 2008
Report
- Report Number
- 9616567-2008-00083
- Event Type
- Malfunction
- Date Received
- October 2, 2008
- Report Date
- August 28, 2008
- Manufacturer
- SMITHS MEDICAL, ASD
- Product Code
- FMF
- PMA / PMN Number
- K883094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SMITHS HAS RECEIVED SAMPLES FROM THE CUSTOMER; HOWEVER, THE INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. SMITHS RECOGNIZES THAT THIS REPORT IS NOT BEING SUBMITTED WITHIN THE REQUIRED TIMEFRAME DUE TO A RECORDING ERROR. MDR REPORTING DEADLINE BASED UPON THE DATE THE INFORMATION WAS RECEIVED WAS SEPTEMBER 26, 2008. SMITHS CONTINUES TO BE COMMITTED TO REGULATORY COMPLIANCE AND WILL MAKE EVERY EFFORT TO ENSURE THAT THIS DOES NOT RECUR.
Description of Event or Problem · 1
THE REPORTER STATED THAT THE VALVE AT THE TOP OF THE SYRINGE FELL OFF DURING USE RESULTING IN A DRUG LEAK. THERE WERE NO FURTHER DETAILS AVAILABLE AS TO INJURY OR TREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 12 CC CONTROL SYRINGE | CONTROL SYRINGE | FMF | SMITHS MEDICAL, ASD | NA | 1271657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |