MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-05 for MEDCOMP VASCU 5F PERIPHERALLY INSERTED CENTRAL CATHETER VASCU-PICC 5F MRVSP52012 manufactured by Medical Components.
[85003663]
Have found three kits 5f x 60 cm dual vascu-picc with the guidewire (within the kit) loaded into holder in reverse (hard stiff end exposed while floppy end in deep within holder). Have found three such kits to date with all being same lot #. Concern is that someone might insert the stiff end potentially causing damage to the vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5071948 |
| MDR Report Key | 6843215 |
| Date Received | 2017-09-05 |
| Date of Report | 2017-08-24 |
| Date Added to Maude | 2017-09-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDCOMP VASCU 5F PERIPHERALLY INSERTED CENTRAL CATHETER |
| Generic Name | PERCUTANEOUS, IMPLANTED LONG TERM INTRAVASCULAR CATHETER |
| Product Code | OMF |
| Date Received | 2017-09-05 |
| Model Number | VASCU-PICC 5F |
| Catalog Number | MRVSP52012 |
| Lot Number | MJBB690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL COMPONENTS |
| Manufacturer Address | HARLEYEYSVILLE PA 19438 US 19438 |
| Brand Name | MEDCOMP VASCU 5F PERIPHERALLY INSERTED CENTRAL CATHETER |
| Generic Name | PERCUTANEOUS, IMPLANTED LONG TERM INTRAVASCULAR CATHETER |
| Product Code | OMF |
| Date Received | 2017-09-05 |
| Model Number | VASCU-PICC 5F |
| Catalog Number | MRVSP52012 |
| Lot Number | MJBB690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL COMPONENTS |
| Manufacturer Address | HARLEYEYSVILLE PA 19438 US 19438 |
| Brand Name | MEDCOMP VASCU 5F PERIPHERALLY INSERTED CENTRAL CATHETER |
| Generic Name | PERCUTANEOUS, IMPLANTED LONG TERM INTRAVASCULAR CATHETER |
| Product Code | OMF |
| Date Received | 2017-09-05 |
| Model Number | VASCU-PICC 5F |
| Catalog Number | MRVSP52012 |
| Lot Number | MJBB690 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL COMPONENTS |
| Manufacturer Address | HARLEYEYSVILLE PA 19438 US 19438 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-05 |