FDA Adverse Event
Injury
Summary report: N
HICKMAN CATHETER
MDR report key: 6137965
·
Received November 28, 2016
Report
- Report Number
- MW5066436
- Event Type
- Injury
- Date Received
- November 28, 2016
- Date of Event
- November 20, 2016
- Report Date
- November 25, 2016
- Manufacturer
- UNK
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
PT REMS ID: (B)(6). PROVIDER REMS ID: (B)(6). DATE OF AWARENESS: (B)(6) 2016. PT IS A (B)(6) Y/O FEMALE ON LETAIRIS FOR PAH. PT REPORTED TO PHARMACIST AT DISPENSING PHARMACY REGARDING HOSPITAL ADMISSION FROM (B)(6) 2016 FOR CATHETER LEAK. PER CHART REVIEW, PT WAS ADMITTED ON(B)(6) 2016 FOR HICKMAN CATHETER LEAK. PT REMAINED IN THE HOSPITAL UNTIL (B)(6) 2016 FOR OBSERVATION. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: 416.8 PAH (CONNECTIVE TISSUE/CONGENITAL HEART DZ.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780895 | HICKMAN CATHETER | HICKMAN CATHETER | LJS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Hospitalization | DOSE OR AMOUNT: 10MG, FREQUENCY: QD, | LETAIRIS 10MG TAB 30/BO: 10MG, MFR: GILEAD,| NDC # 61958-0802-01, LOT # 1513380A, | ROUTE: ORAL, EXP: |