FDA Adverse Event
Malfunction
Summary report: N
PVL 2555 #HLS CANNULA 25F
MDR report key: 2772377
·
Received October 2, 2012
Report
- Report Number
- 8010762-2012-00039
- Event Type
- Malfunction
- Date Received
- October 2, 2012
- Date of Event
- August 28, 2012
- Report Date
- September 7, 2012
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- DWF
- PMA / PMN Number
- K102532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
MAQUET MEDICAL SYSTEMS, USA, SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE, MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE IS BEING RETURNED TO THE FACTORY FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE PROVIDED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE LUMEN OF THE INTRODUCER WAS OBSTRUCTED. THIS MADE IT IMPOSSIBLE TO PASS THE INTRODUCER OVER THE GUIDEWIRE. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PVL 2555 #HLS CANNULA 25F | VENOUS HLS CANNULA | DWF | MAQUET CARDIOPULMONARY AG | PVL 2555 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |