MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for POWERGLIDE ST MIDLINE CATHETER manufactured by Bard Access Systems, Inc..
[184848271]
Prior to placing a midline catheter, needle and introducer/catheter are checked for patency. While doing this, it was noticed that the guidewire does not smoothly glide into the steel needle. It needed to be pushed with pressure to get through. The midline kit used- lot# redx4347. No harm reached patient as this was found out pre-procedure. Have informed and reached out to the manufacturer representative for response and/or resolution. Manufacturer response for midline catheter, powerglide st midline catheter (per site reporter). Awaiting the response from the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9877433 |
| MDR Report Key | 9877433 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-02-15 |
| Date of Event | 2020-02-07 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-03-25 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| 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 | POWERGLIDE ST MIDLINE CATHETER |
| Generic Name | MIDLINE CATHETER |
| Product Code | PND |
| Date Received | 2020-03-25 |
| Lot Number | REDX4347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2020-03-25 |