MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-16 for POWER PICC SOLO*2 CATHETER WITH SHERLOCK 3CG* TPS STYLET KIT manufactured by C.r. Bard, Inc..
[4836644]
Difficulty activating scalpel from picc kit. Device button seemed to stick. Trying to force it open when my hand slipped, the device opened, and the scalpel poked into my skin under my 5th finger on the palm of my right hand. The poke happened prior to the device having contact with the patient's skin who (b)(6). Injury site cleaned and dressed. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4095181 |
| MDR Report Key | 4095181 |
| Date Received | 2014-09-16 |
| Date of Report | 2014-09-16 |
| Date of Event | 2014-07-11 |
| Report Date | 2014-09-16 |
| Date Reported to FDA | 2014-09-16 |
| Date Reported to Mfgr | 2014-09-17 |
| Date Added to Maude | 2014-09-17 |
| 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 | POWER PICC SOLO*2 CATHETER WITH SHERLOCK 3CG* TPS STYLET KIT |
| Generic Name | KIT, CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER TH |
| Product Code | GDX |
| Date Received | 2014-09-16 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | REYD1845 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. |
| Manufacturer Address | 730 CENTRAL AVE. MURRAY HILL NJ 07974 US 07974 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2014-09-16 |