MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-27 for JELCO? VIAVALVE? SAFETY IV CATHETER 326600 manufactured by Smiths Medical Asd; Inc..
[185196928]
Information was received indicating that upon removal of a smiths medical jelco? Viavalve? Safety iv catheter, the end came off and the catheter stayed in the vein. It was reported that bleeding had started around the insertion site and the iv was attempted to be removed. Subsequently, the catheter was then removed from the patient's skin. There were no further reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02195 |
| MDR Report Key | 9887347 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-27 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS,, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA, |
| Manufacturer Street | 201 WEST QUEEN STREET |
| Manufacturer City | SOUTHINGTON, CT |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JELCO? VIAVALVE? SAFETY IV CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
| Product Code | FOZ |
| Date Received | 2020-03-27 |
| Model Number | 326600 |
| Catalog Number | 326600 |
| Lot Number | 3850522 |
| Operator | HEALTH PROFESSIONAL |
| 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 N MINNEAPOLIS,, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |