MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for CADD EXT SET 60 manufactured by Smiths Medical Asd, Inc..
[102952052]
Inbound pt reports her tubing leaking today, states this is the 3rd tubing in last 3 days doing this, thinks the leaking is coming out by the filter. Lot number of today's leaking tubing 57x474. No further details provided. Diagnosis or reason for use: sph.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075963 |
| MDR Report Key | 7352183 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-03-05 |
| Date Added to Maude | 2018-03-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| 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 | CADD EXT SET 60 |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2018-03-19 |
| Lot Number | 57X474 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Brand Name | CADD EXT SET 60 |
| Generic Name | TUBING |
| Product Code | BYX |
| Date Received | 2018-03-19 |
| Lot Number | 57X474 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-19 |