FDA Adverse Event
Injury
Summary report: N
PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS
MDR report key: 3833402
·
Received May 19, 2014
Report
- Report Number
- 2183502-2014-00315
- Event Type
- Injury
- Date Received
- May 19, 2014
- Report Date
- May 16, 2014
- Manufacturer
- SMITHS MEDICAL MD, INC.
- Product Code
- CAZ
- PMA / PMN Number
- K965017
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED, THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.
Description of Event or Problem · 1
USER FACILITY REPORTED THAT THE DEVICE WAS PLACED IN USE WITH PATIENT AND THE LOSS OF RESISTANCE SYRINGE COMPONENT WAS NOT PROVIDING PROPER FEEDBACK DURING EPIDURAL PLACEMENT. ACCORDING TO REPORTER, PATIENT RECEIVED DURA PUNCTURE. PATIENT RECEIVED AN EPIDURAL BLOOD PATCH AND WAS GIVEN VARIOUS ANALGESIC MEDICATIONS FOR APPROXIMATELY ONE WEEK. NO PERMANENT ADVERSE EFFECTS TO PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295771 | PORTEX COMBINED SPINAL EPIDURAL ANESTHESIA TRAYS | CAZ-ANESTHESIA CONDUCTION | CAZ | SMITHS MEDICAL MD, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |