FDA Adverse Event
Malfunction
Summary report: N
1CC SAF SYR ETB 25X 5/8
MDR report key: 1060989
·
Received June 12, 2008
Report
- Report Number
- 1915484-2008-00025
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- May 9, 2008
- Report Date
- May 15, 2008
- Manufacturer
- TYCO HEALTHCARE/KENDALL
- Product Code
- FMF
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS UNDER WAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL IN 2008 THAT A CUSTOMER HAD A PROBLEM WITH A KENDALL MONOJECT SYRINGE. THE CUSTOMER STATED THAT A NURSE INADVERTENTLY REC'D A CONTAMINATED NEEDLE STICK BECAUSE THE HUB DID NOT FIRMLY ADHERE TO THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1CC SAF SYR ETB 25X 5/8 | KENDALL MONOJECT TUBERCULIN SYRINGE | FMF | TYCO HEALTHCARE/KENDALL | 8881511235 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |