FDA Adverse Event
Injury
Summary report: N
CENTURION KLEEN NEEDLE HEPLOCK
MDR report key: 14587
·
Received July 8, 1994
Report
- Report Number
- MW1002757
- Event Type
- Injury
- Date Received
- July 8, 1994
- Date of Event
- June 23, 1994
- Report Date
- June 27, 1994
- Manufacturer
- TRI-STATE HOSPITAL SUPPLY CORP.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DEFECTIVE COMPONENT. PT PHONED TO REPORT INABILITY TO CONNECT REPLACEMENT HEPARIN LOCK CAP TO EXISTING CENTRAL LINE. NURSING VISIT OBSERVATION REVEALED FRACTURED/SHEARED INNER CANNULA FROM HEPARIN LOCK, TO BE THREADED/RECESSED INTO LUMEN CONNECTOR OF CENTRAL LINE. PT RECEIVING DAILY/CYCLICAL 3-1 TPN. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTURION KLEEN NEEDLE HEPLOCK | HEPARIN LOCK CAP | FOZ | TRI-STATE HOSPITAL SUPPLY CORP. | 10132, 1105, 07272 OR 05202 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other| R | GROSHONG CATHTER FOR CVA |