MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-06 for WEBCOL ALCOHOL PREP, 2PLY MEDIUM manufactured by Covidien / Cardinal Health 200, Llc.
[182894727]
Rn was teaching a pt how to infuse medication and flush iv line. Rn watched as the pt opened an alcohol wipe and the rn noticed a black piece of particulate matter on the wipe. Rn immediately stopped the pt, gave the pt a new wipe and continued with the return demonstration. Rn took picture of affected alcohol wipe and returned the rest of the box back the system qa for review.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093606 |
| MDR Report Key | 9805155 |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-25 |
| Date Added to Maude | 2020-03-09 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEBCOL ALCOHOL PREP, 2PLY MEDIUM |
| Generic Name | PAD, ALCOHOL, DEVICE DISINFECTANT |
| Product Code | LKB |
| Date Received | 2020-03-06 |
| Lot Number | 19E124062 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN / CARDINAL HEALTH 200, LLC |
| Brand Name | 70 % PERCENT |
| Product Code | --- |
| Date Received | 2020-03-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |