MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-02 for PERIPHERAL CATHETER INSERTION KIT AC0182250 manufactured by Bard Access Systems, Inc..
[87870781]
Patient Sequence No: 1, Text Type: N, H10
[87870782]
Nurse attempted to insert a guide wire ultrasound iv, the guidewire was advanced, but would not go any further. Nurse tried to retract, and it would not come back into chamber. Nurse attempted to retract needle with difficulty, but was managed. Needle was retracted but guide wire remained in patients arm. Nurse was able to pull guide wire out with force from pts arm. Guide wire appeared to be intact. Packaging saved but needle/chamber/guidewire was disposed of in biohazard sharps container.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6906659 |
| MDR Report Key | 6906659 |
| Date Received | 2017-10-02 |
| Date of Report | 2017-09-28 |
| Date of Event | 2017-09-26 |
| Report Date | 2017-09-28 |
| Date Reported to FDA | 2017-09-28 |
| Date Reported to Mfgr | 2017-09-28 |
| Date Added to Maude | 2017-10-02 |
| 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 |
| 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 | PERIPHERAL CATHETER INSERTION KIT |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS |
| Product Code | OWL |
| Date Received | 2017-10-02 |
| Model Number | AC0182250 |
| Catalog Number | AC0182250 |
| Lot Number | REBV0326 |
| Device Expiration Date | 2018-12-31 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Manufacturer Address | 605 NORTH 5600 WEST SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-02 |