MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for CLOSED SYSTEM TRANSFER DEVICE CH351 manufactured by Icu Medical, Inc..
[180740059]
Chemotherapy found to be leaking from adaptor onto floor. Estimated 100 mls loss volume. Chemo leaking male iv tubing to the closed system device. Close system transfer device is securely connected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9750104 |
| MDR Report Key | 9750104 |
| Date Received | 2020-02-25 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-24 |
| Report Date | 2020-01-28 |
| Date Reported to FDA | 2020-01-28 |
| Date Reported to Mfgr | 2020-02-25 |
| Date Added to Maude | 2020-02-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLOSED SYSTEM TRANSFER DEVICE |
| Generic Name | CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM |
| Product Code | ONB |
| Date Received | 2020-02-25 |
| Catalog Number | CH351 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL, INC. |
| Manufacturer Address | 951 CALLE AMANECER SAN CLEMENTE CA 92673 US 92673 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-25 |