MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-20 for BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM) N/A P6154118 manufactured by Bard Access Systems.
[184329101]
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of redt1694 showed five other similar product complaint(s) from this lot number. The complaints for this lot number have been reported from the same facility in finland.
Patient Sequence No: 1, Text Type: N, H10
[184329102]
It was reported customer has insert powermidline on the patient and after a while there has been thrombosis symptoms and after ultrasounding they have found big thrombosis on the vein.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00965 |
| MDR Report Key | 9861160 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-06-01 |
| Date Added to Maude | 2020-03-20 |
| 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 | KAYLA OLSEN |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225010 |
| 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 | BARD POWERMIDLINE CATHETER BASIC KIT (4F) (SINGLE-LUMEN) (20CM) |
| Generic Name | MIDLINE CATHETER |
| Product Code | PND |
| Date Received | 2020-03-20 |
| Model Number | N/A |
| Catalog Number | P6154118 |
| Lot Number | REDT1694 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2020-03-20 |