FDA Adverse Event
Injury
Summary report: N
DTX SAFEDRAW KITS
MDR report key: 20081774
·
Received August 27, 2024
Report
- Report Number
- 8020616-2024-00022
- Event Type
- Injury
- Date Received
- August 27, 2024
- Date of Event
- May 27, 2024
- Report Date
- August 20, 2024
- Manufacturer
- MERIT MEDICAL SINGAPORE PTE LTD.
- Product Code
- DSK
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE SUSPECT DEVICE IS EXPECTED TO RETURN FOR EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.
Additional Manufacturer Narrative · 0
THE SUSPECT MEDICAL DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY AND MICROSCOPICALLY INVESTIGATED. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE IS ATTRIBUTED TO OVER-TIGHTENING DURING PRODUCT APPLICATION OR PREPARATION. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO EXCEPTION DOCUMENTS WERE FOUND. A SEARCH OF THE COMPLAINT DATABASE WAS PERFORMED AND NO SIMILAR COMPLAINTS FOR THIS LOT NUMBER WERE IDENTIFIED.
Description of Event or Problem · 0
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE LEAKED NEAR THE PLANECTA. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191296 | DTX SAFEDRAW KITS | COMPUTER, BLOOD-PRESSURE | DSK | MERIT MEDICAL SINGAPORE PTE LTD. | C2794685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |