MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-08-20 for CHLORAPREP * 69581 manufactured by Medical Action Industries Inc.
[3839168]
Rn was starting an iv using chloraprep from iv start kit. While scrubbing arm to clean off area, patient stated it was hurting. Upon examination, the patient's arm had scratches all over from chloraprep glass. Basic first aid was provided: site cleaned and dressed. No harm to the healthcare provider. This is the second event at this facility with this type of product. ====================== manufacturer response for chloraprep, (brand not provided) (per site reporter). ====================== carefusion opening a complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3321388 |
| MDR Report Key | 3321388 |
| Date Received | 2013-08-20 |
| Date of Report | 2013-08-20 |
| Date of Event | 2013-08-19 |
| Report Date | 2013-08-20 |
| Date Reported to FDA | 2013-08-20 |
| Date Reported to Mfgr | 2013-09-03 |
| Date Added to Maude | 2013-09-03 |
| 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 | 0 |
| 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 | CHLORAPREP |
| Generic Name | KIT, I.V. START |
| Product Code | LRS |
| Date Received | 2013-08-20 |
| Model Number | * |
| Catalog Number | 69581 |
| Lot Number | 167964 1.5 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 0 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES INC |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-20 |