FDA Adverse Event
Injury
Summary report: N
1/8 INCH PVC TUBING
MDR report key: 2982918
·
Received February 28, 2013
Report
- Report Number
- 0001811755-2013-00399
- Event Type
- Injury
- Date Received
- February 28, 2013
- Date of Event
- January 15, 2013
- Report Date
- November 18, 2020
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- CAC
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE WILL NOT BE RETURNED FOR EVALUATION
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DRAIN TUBING BROKE UPON REMOVAL OF THE DEVICE FROM THE PATIENT. THE PATIENT REQUIRED REMOVAL OF THE RETAINED DRAIN FRAGMENT IN THE OPERATIING ROOM, WHILE IN CONJUNCTION WITH A POSTERIOR LUMBAR EXPLORATION THE SAME DAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT RELATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86737 | 1/8 INCH PVC TUBING | APPARATUS, AUTOTRANSFUSION | CAC | STRYKER INSTRUMENTS-KALAMAZOO | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |