FDA Adverse Event
Other
Summary report: N
NEOCATH CATHETER
MDR report key: 253645
·
Received December 3, 1999
Report
- Report Number
- 9612233-1999-00023
- Event Type
- Other
- Date Received
- December 3, 1999
- Date of Event
- November 4, 1999
- Report Date
- November 5, 1999
- Manufacturer
- DIAMETRICS MEDICAL, LTD.
- Product Code
- CCE
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSING ASSISTANT
Narratives
Description of Event or Problem · 1
A NEOCATH CATHETER 4 FR, BATCH N43182 WAS INSERTED INTO A NEWBORN, PRE-TERM (25 WEEKS) BABY. A 1/2 NORMAL SALINE AND HEPARIN SOLUTION WAS USED IN ORDER TO KEEP THE LINE OPEN. LEAKAGE OF THE SOLUTION WAS NOTICED BY THE HOSPITAL STAFF. THE CATHETER WAS REMOVED AND RETURNED TO DIAMETRICS MEDICAL LTD FOR INVESTIGATION. THERE WAS NO INJURY TO THE PT OR ADVERSE EVENT AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEOCATH CATHETER | UMBILICAL ARTERY OXYGEN MONITORING SYSTEM | CCE | DIAMETRICS MEDICAL, LTD. | NA1004 | N43182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 DAY |