FDA Adverse Event
Malfunction
Summary report: N
PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL
MDR report key: 534202
·
Received March 12, 2004
Report
- Report Number
- 9615050-2004-00040
- Event Type
- Malfunction
- Date Received
- March 12, 2004
- Date of Event
- November 1, 2003
- Report Date
- November 24, 2003
- Manufacturer
- ABBOTT LABS
- Product Code
- FPA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
REPORT RECEIVED OF A DISCONNECTION. REPORTEDLY, THE DEVICE WAS BEING USED TO INFUSE SALINE FOR A PT. DURING INFUSION, THE MALE ADAPTER DISCONNECTED FROM THE PT'S IV SITE. IT WAS REPORTED THAT THIS WAS DUE TO A LOOSE CONNECTION. THERE WAS NO BLEEDBACK, AS THE INCIDENT "WAS CAUGHT JUST IN TIME". THE IV INSERTION SITE REMAINED PATENT. THE USED SET WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT SET WITHOUT DELAY OR MISSED DOSE. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PRIMARY PLUM SET WITH CONV PIN, SEC CAP PORT, 1 CL | ADMINISTRATION SET | FPA | ABBOTT LABS | NA | 080555H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |