MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM CS-15122-F manufactured by Arrow International Inc..
[186730649]
Qn#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186730650]
It was reported that the dilator tip was found to have burs during usage on the patient after puncture. The device could not be used. A new device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00278 |
| MDR Report Key | 9885568 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-16 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2017-04-03 |
| Date Added to Maude | 2020-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | ARROW INTERNATIONAL CR, A.S. |
| Manufacturer Street | JAMSKA 2359/47 |
| Manufacturer City | ZDAR NAD SAZAVOU 591 01 |
| Manufacturer Country | EZ |
| Manufacturer Postal Code | 591 01 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM |
| Generic Name | CATHETER SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2020-03-26 |
| Catalog Number | CS-15122-F |
| Lot Number | 71F17D0215 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |