MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-11-27 for CADD EXTENSION SETS SET, EXTENSION, 30", M/M, 1.1ML, ASV 12/BX 21-7060-24 manufactured by Smiths Medical Asd,inc.
[168318583]
Information received a smiths medial cadd extension sets customer noticed occlusion, even when pressing on plunger for this was checked during precheck and would not go forward. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-06528 |
| MDR Report Key | 9386681 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-10-31 |
| Device Manufacturer Date | 2019-03-11 |
| Date Added to Maude | 2019-11-27 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD,INC |
| Manufacturer Street | 6000 LANE N |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CADD EXTENSION SETS |
| Generic Name | ACCESSORIES, PUMP, INFUSION |
| Product Code | MRZ |
| Date Received | 2019-11-27 |
| Returned To Mfg | 2019-11-06 |
| Model Number | SET, EXTENSION, 30", M/M, 1.1ML, ASV 12/BX |
| Catalog Number | 21-7060-24 |
| Lot Number | 3776444 |
| 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 MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-27 |