MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for CENTURION-CENTRAL VENOUS ACCESS CATHETERS manufactured by Centurion Medical Products Corp..
[126363535]
Pt for swan ganz change. Upon opening new central line kit, it was noted the plastic connector site of catheter was cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081051 |
| MDR Report Key | 8041918 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-30 |
| Date Added to Maude | 2018-11-06 |
| 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 | CENTURION-CENTRAL VENOUS ACCESS CATHETERS |
| Generic Name | CARDIAC CATHETERIZATION KIT |
| Product Code | OES |
| Date Received | 2018-11-05 |
| Lot Number | 2017092950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-05 |