FDA Adverse Event
Malfunction
Summary report: N
RECEPTAL LINER W/VAC-GUARD
MDR report key: 1170779
·
Received September 15, 2008
Report
- Report Number
- 9613251-2008-00339
- Event Type
- Malfunction
- Date Received
- September 15, 2008
- Date of Event
- August 22, 2008
- Report Date
- August 22, 2008
- Manufacturer
- HOSPIRA LTD.
- Product Code
- GCX
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.
Description of Event or Problem · 1
THE CUSTOMER CONTACT REPORTED NO SUCTION. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT WHEN THE HEALTHCARE PROFESSIONAL ATTEMPTED TO SUCTION THE PATIENT, NO SUCTION WAS NOTED. THE DEVICE WAS REPLACED AND THE SUCTIONING WAS INITIATED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RECEPTAL LINER W/VAC-GUARD | 79-GCX | GCX | HOSPIRA LTD. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |