MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for WEBCOL manufactured by Cardinal Health, Inc..
[177594195]
Webcol (covidien) ref (b)(4): 70% alcohol prep pad opened in iv room. Foreign substance found inside prep pad packaging prior to use. Pad was not used. Package, foreign material and pad placed in plastic baggie.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9665059 |
| MDR Report Key | 9665059 |
| Date Received | 2020-02-04 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-11-27 |
| Report Date | 2019-12-19 |
| Date Reported to FDA | 2019-12-19 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 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 | WEBCOL |
| Generic Name | PAD, ALCOHOL, DEVICE DISINFECTANT |
| Product Code | LKB |
| Date Received | 2020-02-04 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |