FDA Adverse Event
Malfunction
Summary report: N
CONTINUOUS NERVE BLOCK KIT
MDR report key: 3190516
·
Received June 21, 2013
Report
- Report Number
- 1036844-2013-00206
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 20, 2013
- Manufacturer
- ARROW INTL., INC.
- Product Code
- CAZ
- PMA / PMN Number
- K021567
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
IT WAS REPORTED THE ANESTHESIA TECH HAS HAD A PERSISTENT PROBLEM WITH THE GLASS VIALS OF MEDICATION IN HIS KIT. WHEN ATTEMPTING TO OPEN THE VIAL OF 1% LIDOCAINE, THE ENTIRE VIAL CRUSHED IN HIS HAND. IT IS NOT KNOWN IF THIS CAUSED A DELAY IN TREATMENT TO THE PT AND THERE WAS NO PT DEATH OR COMPLICATIONS REPORTED. THEE WAS NO MEDICAL INTERVENTION REQUIRED BY THE ANESTHESIA TECH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283724 | CONTINUOUS NERVE BLOCK KIT | ANESTHESIA PRODUCTS | CAZ | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |