MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for IV TUBING CUSTOM SET B33004 CN-055799 manufactured by Icu Medical Inc..
[180172669]
This is a custom set from icu medical (b33712); i have sent the defective tubing to the company for qa. Lot numbers: 4418284, 4429455, and 4174367. Ref # rma #: (b)(4), item lot product description: b33712 - 4418284 - 38" (97 cm) appx 4. 9 ml, ext set w/2 clave, microclave t-connector, remv 4-way stopcock, 3 clamps, rotating luer, 1 smallbore ext, event: it breaks at the 1-port by the microclave date reported to icu medical: (b)(6) 2020. Ref #rma#: (b)(4) (this is for the 30 times that it happened with different unk lot numbers) item - lot - product description: b33712- unk - 38" (97 cm) appx 4. 9 ml, ext set w2 clave, microclave t-connector, remv 4-way stopcock, 3 clamps, rotating luer, 1 smallbore ext, event: it breaks at the microclave; date reported to icu medical: (b)(6) 2020. At first glance it appears that the microclave is not bonded to the tubing on the t-connector (item (b)(4)), causing it to break. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093046 |
| MDR Report Key | 9727845 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-13 |
| Date Added to Maude | 2020-02-19 |
| 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 |
| 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 | IV TUBING CUSTOM SET |
| Generic Name | STOPCOCK, I.V, SET |
| Product Code | FMG |
| Date Received | 2020-02-18 |
| Model Number | B33004 |
| Catalog Number | CN-055799 |
| Lot Number | 4418284 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC. |
| Brand Name | IV TUBING CUSTOM SET |
| Generic Name | STOPCOCK, I.V, SET |
| Product Code | FMG |
| Date Received | 2020-02-18 |
| Model Number | B33712 |
| Catalog Number | CN-055804 |
| Lot Number | 4429455 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC. |
| Brand Name | IV TUBING CUSTOM SET |
| Generic Name | STOPCOCK, I.V, SET |
| Product Code | FMG |
| Date Received | 2020-02-18 |
| Model Number | B33712 |
| Catalog Number | CN-055804 |
| Lot Number | 4174367 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | ICU MEDICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |