MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2017-01-16 for MEDEX? 500 ML CLEAR-CUFF PRESSURE INFUSOR MX4705 manufactured by Smiths Medical Asd, Inc..
[64913210]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[64913211]
It was reported that the medex pressurizing bag would not hold the correct pressure. There were no adverse health outcomes reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2017-00004 |
| MDR Report Key | 6253111 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2017-01-16 |
| Date of Report | 2015-03-30 |
| Date Mfgr Received | 2015-03-30 |
| Date Added to Maude | 2017-01-16 |
| 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 | MS. 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? 500 ML CLEAR-CUFF PRESSURE INFUSOR |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-01-16 |
| Catalog Number | MX4705 |
| Lot Number | 2626556 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-01-16 |