MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-23 for LEADERFLEX 22G 20CM 1212.20 manufactured by Vygon Gmbh.
[186731545]
One failed sample and several unopened samples from the same lot have been returned to vygon and will be evaluated as part of the complaint investigation. The results of this investigation are still pending and will be communicated to fda within 30 days of completion. There were 5 occurrences of this issue, the details for the events can be found in the following reports: 2245270-2020-00014, 2245270-2020-00015, 2245270-2020-00016, 2245270-2020-00017.
Patient Sequence No: 1, Text Type: N, H10
[186731546]
At least 5 20cm leaderflex catheters being used as piccs have broken at various points of usage, from insertion, during dwell, to removal. No harm to patients reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2245270-2020-00013 |
| MDR Report Key | 9866527 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CLAIRE PADDOCK |
| Manufacturer Street | 2750 MORRIS ROAD |
| Manufacturer City | LANSDALE, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 4735414 |
| Manufacturer G1 | VYGON GMBH |
| Manufacturer Street | PRAGER RING 100 |
| Manufacturer City | AACHEN, 52070 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 52070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEADERFLEX 22G 20CM |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | FOZ |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-18 |
| Model Number | 1212.20 |
| Catalog Number | 1212.20 |
| Lot Number | 290519GH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYGON GMBH |
| Manufacturer Address | PRAGER RING 100 AACHEN, 52070 GM 52070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |