FDA Adverse Event
Death
Summary report: N
PORTEX® EPIDURAL MINIPACKS
MDR report key: 7848691
·
Received September 5, 2018
Report
- Report Number
- 3012307300-2018-03584
- Event Type
- Death
- Date Received
- September 5, 2018
- Date of Event
- April 5, 2018
- Report Date
- April 22, 2019
- Manufacturer
- SMITHS MEDICAL ASD; INC.
- Product Code
- CAZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
REPORT SOURCE: (B)(6)
Description of Event or Problem · 1
INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL PORTEX® EPIDURAL MINIPACK, THE CATHETER RUPTURED; LEAVING APPROXIMATELY 15CM OF CATHETER INSIDE THE PATIENT. IT WAS REPORTED THAT THE CATHETER WAS BEING ATTEMPTED TO BE REMOVED 2-3CM DUE TO MOTOR AND SENSITIVE BLOCKAGE OF THE CONTRALATERAL SIDE. EXPLORATION WAS NECESSARY SUPERFICIALLY BUT THE DISTAL END OF THE CATHETER WAS NOT NOTED. NEUROSURGERY WAS THEN CONSULTED AND INTRAVENOUS ANALGESIA WAS CONTINUED. THERE WAS NO FURTHER ADVERSE EFFECTS REPORTED.
Description of Event or Problem · 1
ADDITIONAL PATIENT INFORMATION WAS RECEIVED THAT THE PATIENT HAS DIED. THE CUSTOMER STATED THAT THE DEATH WAS NOT DEVICE RELATED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686329 | PORTEX® EPIDURAL MINIPACKS | ANESTHESIA CONDUCTION KIT | CAZ | SMITHS MEDICAL ASD; INC. | 3528085 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Death| H| R |