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 |