MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-17 for PERIPHERAL CATHETER INSERTION KIT AC0182250 manufactured by Bard Access Systems, Inc..
[80141881]
Patient Sequence No: 1, Text Type: N, H10
[80141882]
The needle would not retract during ultrasound iv placement and while correction placement was being obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6716849 |
| MDR Report Key | 6716849 |
| Date Received | 2017-07-17 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-24 |
| Report Date | 2017-06-26 |
| Date Reported to FDA | 2017-06-26 |
| Date Reported to Mfgr | 2017-06-26 |
| Date Added to Maude | 2017-07-17 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 |
| Product Code | OWL |
| Date Received | 2017-07-17 |
| Model Number | AC0182250 |
| Catalog Number | AC0182250 |
| Lot Number | REBS0488 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 0 YR |
| 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 | 2017-07-17 |