FDA Adverse Event
Other
Summary report: N
PORTEX CONTINUOUS EPIDURAL 17 GAUGE TUOHY
MDR report key: 743626
·
Received June 1, 2005
Report
- Report Number
- MW1035599
- Event Type
- Other
- Date Received
- June 1, 2005
- Date of Event
- May 16, 2005
- Report Date
- May 27, 2005
- Manufacturer
- SMITHS MEDICAL ASD, INC
- Product Code
- MIA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CRNA ATTEMPTING TO PLACE CONTINUOUS EPIDURAL FOR PT DURING LABOR. AFTER PLACING THE NEEDLE, THE CRNA ATTEMPTED TO CONNECT NEEDLE TO TUBING. THE NEEDLE WOULD NOT CONNECT SECURELY TO THE PHLANGE OF THE SYRINGE DUE TO BREAKAGE AROUND THE NECK OF THE NEEDLE. THE CRNA HAD TO REMOVE THE NEEDLE AND REPLACE IT WITH A NEW ONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PORTEX CONTINUOUS EPIDURAL 17 GAUGE TUOHY | TUOHY EPIDURAL NEEDLE | MIA | SMITHS MEDICAL ASD, INC | A3165-17 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |