N
Patient 1
THE DEVICE IS CURRENTLY BEING EVALUATED; SMITHS MEDICAL WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. DEVICE EVALUATION IN PROGRESS.
MAUDE MDR 6569151
- MDR report key
- 6569151
- Report number
- 3012307300-2017-01084
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-04-18
- Date received
- 2017-05-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- JENNIFER MENG
- Address
- 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US
- Phone
- 763-763-7633
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MEDEX? CLEAR-CUFF PRESSURE INFUSOR | INFUSOR, PRESSURE, FOR I.V. BAGS | SMITHS MEDICAL ASD, INC. | KZD | MX4705 | 3317569 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-16 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT A MEDEX? CLEAR-CUFF PRESSURE INFUSOR HAD BURRS AND WAS LEAKING. NO INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01012, 3012307300-2017-01077, 3012307300-2017-01078, 3012307300-2017-01079, 3012307300-2017-01080, 3012307300-2017-01081, 3012307300-2017-01082, 3012307300-2017-01083, 3012307300-2017-01085, AND 3012307300-2017-01086, AND 3012307300-2017-01087.
N
Patient 1
TWELVE DEVICES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICES DISCOVERED SMALL BURRS ON THE SIDE OF THE BAGS. FUNCTIONAL TESTING INVOLVED A LEAK TEST AND ALL TWELVE DEVICES WERE INFLATED AND LEFT OVERNIGHT; IT WAS OBSERVED THAT THE DEVICES HELD THE SAME AMOUNT OF AIR THAT THE DEVICES WERE INFLATED WITH, AND THEREFORE THE LEAKING WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING PROCESS IDENTIFIED THAT DIES THAT WERE USED TO CUT THE DEVICE WERE DULL AND NEEDED ADJUSTMENT, WHICH WAS CORRECTED PRIOR TO THE PRODUCTION OF THE REPORTED LOT. BASED ON THE EVIDENCE, THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THE RETURNED DEVICE FUNCTIONED AS SPECIFIED. THERE WAS NO EVIDENCE TO INDICATE THAT THERE WAS AN INTRINSIC DEFECT IN THE PRODUCT.