FDA Adverse Event
Death
Summary report: N
V-CATH
MDR report key: 123548
·
Received October 1, 1997
Report
- Report Number
- 2925153-1997-00011
- Event Type
- Death
- Date Received
- October 1, 1997
- Date of Event
- August 30, 1997
- Report Date
- September 17, 1997
- Manufacturer
- HDC CORP.
- Product Code
- DQO
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MIDLINE CATHETER WAS INSERTED INTO LEFT ANTECUBITAL VEIN OF A 81 YR OLD FEMALE PT WHO WAS BEEN TREATED FOR PNEUMONIA. NEXT DAY NURSE NOTICED APPROX ONE INCH OF TUBING WAS LYING ON SKIN UNDER THE TRANSPARENT DRESSING. AFTER REMOVING, NURSE DID NOT OBSERVED THE REMAINDER OF TUBING. X-RAYS OF SEVERAL AREAS OF PT'S BODY WERE TAKEN AND NO FORIEGN BODY WAS FOUND. PT'S CONDITION IS FINE, AND NO SYMPTOMS OR REACTIONS WERE REPORTED SINCE 08/30/97.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V-CATH | MIDLINE | DQO | HDC CORP. | 360-08 | 1063 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |