MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2015-04-01 for LIV VALVE ROTAREX / CEODEUX REF: LIV LINDE DISS 0,750-16UNF MAXIFLOW manufactured by .
[5732360]
This spontaneous med device incident report from a customer in (b)(6), the (b)(6), involves a stem of cylinder linde integrated valve (liv) manufactured by (b)(4). On (b)(6) the (b)(6) reported an incident concerning a liv, which presented a valve fracture at the stem. The incident occurred when the cylinder was not in use and stowed with nine more cylinders. The incident did not cause harm to people but it caused minor damages to the infrastructure of the storage area at the customer's site. The cylinder and valve were immediately collected for further investigation and material analysis. A recall has been initiated by the plant. This case is linked to co-lhc-2015040 due to similar incidents from the same batch. Due to the similarity of failure mechanism and the same location these incidents are subject to a common investigation and will be managed as a single mir, 15-25 ras. Cylinder brand: luxfer, 5 liters (portable type). Valve brand and reference: liv valve (b)(4) reference liv linde diss 0,750-16unf maxiflow, both equipment suitable for filling at 200 bar. Risks: the detachment of the valve might hit other cylinders or valves causing an ignition after spark generation. The sudden release of pressure and consequent expel of the valve can impact operators or third parties, damage equipment or infrastructure. Additional info is expected.
Patient Sequence No: 1, Text Type: D, B5
[13181545]
Report from (b)(6); cylinder neck broken, unclear whether there possibly could be a device defect or if it is associated to external forces. Investigation ongoing. Device incident, no pt/human harm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2015-00003 |
| MDR Report Key | 4663980 |
| Report Source | 00,01,05 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-04-01 |
| Date of Event | 2015-03-02 |
| Date Mfgr Received | 2015-03-02 |
| Date Added to Maude | 2015-05-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | AGAVAGEN 54 |
| Manufacturer City | LIDINGO 181 81 |
| Manufacturer Country | SW |
| Manufacturer Postal | 181 81 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIV VALVE ROTAREX / CEODEUX REF: LIV LINDE DISS 0,750-16UNF MAXIFLOW |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2015-04-01 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-01 |