MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER) N/A 7655405 manufactured by Bard Access Systems.
[186602582]
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred. A lot history review (lhr) of recn0574 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[186603383]
It was reported that patient was hospitalized on (b)(6) 2018, and diagnosed with postoperative cerebral hemorrhage, epileptic seizure, lung infection, and severe malnutrition. On (b)(6) 2019, the patient underwent picc catheterization from the left basilic vein under the guidance of ultrasound and along with the seldinger technique. 42 cm of the catheter was placed in the body with another 5cm externally and the tip at the 7th posterior rib. Normal maintenance was done during hospitalization, and no high-pressure injection was used. However, no blood could not be aspirated in recent days with occasional blood return. Resistance was met when the catheter was being flushed. On (b)(6) 2020, the catheter was withdrawn. In the process of removal, normal saline was used to flush the tube and gentle force was applied. However, the catheter was broken off at the 21 cm mark, with a part left in the body. Bandage was immediately applied above the puncture site and invited the radiology department to perform bed-side chest radiography and vascular color doppler ultrasound for location of the catheter. The general surgery department was invited for consultation and the catheter was withdrawn in the operating room
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00991 |
| MDR Report Key | 9877864 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2020-03-25 |
| 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 | GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY (WITH MICROINTRODUCER) |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
| Product Code | LJS |
| Date Received | 2020-03-25 |
| Model Number | N/A |
| Catalog Number | 7655405 |
| Lot Number | RECN0574 |
| 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 | 2020-03-25 |