MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-13 for MEDEX? CLEAR-CUFF PRESSURE INFUSOR MX4705 manufactured by Smiths Medical Asd, Inc..
[65204731]
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.
Patient Sequence No: 1, Text Type: N, H10
[65204732]
It was reported that a medex? Clear-cuff pressure infusor had leaked. This incident was observed during testing after the infusor had been inflated and had sat overnight for around 15 hours. No patient was involved.
Patient Sequence No: 1, Text Type: D, B5
[68042030]
One medex? Clear-cuff pressure infusor was returned for investigation. A review of the device history record, relevant to the reported lot, found no issues during manufacturing. During visual and functional testing, the returned device was inflated multiple times and an air leak was found. The leak was located at the plunger end of the assembly unit. Investigation determined that the root cause of the leak was due to a manufacturing issue and was an exception in the initial manufacturing of the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-00192 |
| MDR Report Key | 6249004 |
| Date Received | 2017-01-13 |
| Date of Report | 2016-12-23 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2017-01-30 |
| Device Manufacturer Date | 2014-09-17 |
| Date Added to Maude | 2017-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA PERZ |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL ASD INC |
| Manufacturer Street | 6250 SHIER RINGS ROAD, |
| Manufacturer City | DUBLIN OH 43016 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 43016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX? CLEAR-CUFF PRESSURE INFUSOR |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-01-13 |
| Returned To Mfg | 2017-01-09 |
| Catalog Number | MX4705 |
| Lot Number | 2786208 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-13 |