FDA Adverse Event
Death
Summary report: N
AKCESS CATH-KIT
MDR report key: 6268
·
Received August 16, 1993
Report
- Report Number
- 6268
- Event Type
- Death
- Date Received
- August 16, 1993
- Date of Event
- June 17, 1993
- Report Date
- June 28, 1993
- Manufacturer
- NEOSTAR MEDICAL TECHNOLOGIES, INC.
- Product Code
- BSY
- Adverse Event
- Yes
- Report Source
- User Facility report
Narratives
Description of Event or Problem · 1
ON 17 JUNE 1993, A 65 Y/O WOMADEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. THE DEVICE WAS DESTROYED/DISPOSED OF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AKCESS CATH-KIT | PERMA CATH | BSY | NEOSTAR MEDICAL TECHNOLOGIES, INC. | AC-190K | AR154 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |