MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for CHLORAPREP 260815 manufactured by Becton, Dickinson & Co..
[105397627]
Patient Sequence No: 1, Text Type: N, H10
[105397628]
Orange dye has bled through to sponge while still inside sterile package - entire lot affected. Manufacturer response for chloraprep 26ml, (brand not provided) (per site reporter). Rep came in and traded out for another lot number. Although bd does not view this as an failure (not activated), our surgical team has chosen not to use this lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7428445 |
| MDR Report Key | 7428445 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-03-13 |
| Report Date | 2018-03-20 |
| Date Reported to FDA | 2018-03-20 |
| Date Reported to Mfgr | 2018-03-20 |
| Date Added to Maude | 2018-04-13 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | CHLORAPREP |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, NON-STERILE |
| Product Code | KXF |
| Date Received | 2018-04-13 |
| Returned To Mfg | 2018-03-19 |
| Catalog Number | 260815 |
| Lot Number | 8026672 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |