MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-07 for POWERMIDLINE CATHETER, 4F SL N/A CK000799 manufactured by Bard Access Systems.
[188743708]
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of redw2246 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[188743709]
It was reported the us (ultra sound) gel was leaking though the sterile probe cover that came with the kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00439 |
| MDR Report Key | 9682558 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-09-01 |
| Date Added to Maude | 2020-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERMIDLINE CATHETER, 4F SL |
| Generic Name | MIDLINE CATHETER |
| Product Code | PND |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-01-29 |
| Model Number | N/A |
| Catalog Number | CK000799 |
| Lot Number | REDW2246 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |