MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2020-03-31 for JELCO? IV CATHETER 4038-AI manufactured by Smiths Medical Asd; Inc..
[185915450]
Information was received indicating that upon removal of a smiths medical jelco iv catheter, the cannula broke off in the patient. The patient was reported to be taken to surgery for successful removal of the retained piece. The patient recovered and was discharged. There were no further reported adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02640 |
| MDR Report Key | 9908301 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-29 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2020-03-31 |
| 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 INTERNATIONAL LTD |
| Manufacturer Street | 1500, EUREKA PARK LOWER PEMBERTON |
| Manufacturer City | ASHFORD, KENT TN254BF |
| Manufacturer Country | UK |
| Manufacturer Postal Code | TN25 4BF |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JELCO? IV CATHETER |
| Generic Name | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS |
| Product Code | FOZ |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-25 |
| Catalog Number | 4038-AI |
| Lot Number | 3738126 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-31 |