MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-21 for CHLORAPREP ONE-STEP 260400 manufactured by Becton, Dickinson & Co..
[145620520]
Nurse was placing a peripherally inserted central catheter (picc) and prepared sterile field by dropping a chloraprep one-step onto the field. During placement, the nurse attempted to cleanse the site. When the chloraprep was attempted to be utilized, the nurse snapped the wings to release the fluid but there was no snap and then the nurse noted that there was no fluid in the chamber. Another nurse dropped another chloraprep onto the field, and when the nurse went to use this cleanser device, the same occurred requiring a third chloraprep to be utilized. Both prior chlorapreps came from the same lot number.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8627066 |
| MDR Report Key | 8627066 |
| Date Received | 2019-05-21 |
| Date of Report | 2019-04-03 |
| Date of Event | 2019-03-14 |
| Report Date | 2019-04-03 |
| Date Reported to FDA | 2019-04-03 |
| Date Reported to Mfgr | 2019-05-21 |
| Date Added to Maude | 2019-05-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | CHLORAPREP ONE-STEP |
| Generic Name | APPLICATOR, ABSORBENT TIPPED, NON-STERILE |
| Product Code | KXF |
| Date Received | 2019-05-21 |
| Model Number | 260400 |
| Catalog Number | 260400 |
| Lot Number | 8331695 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-05-21 |