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 2019-10-21 for ARROW DRAINAGE SET AI-01600 manufactured by Arrow International Inc..
[177960823]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177960824]
The customer reports: the flange that sits over the tube and is stitched into the patient is too large for the pipe. If the patient moves, the flange remains but the pipe falls out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2019-00396 |
| MDR Report Key | 9213289 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-10-21 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2019-11-18 |
| Device Manufacturer Date | 2019-02-20 |
| Date Added to Maude | 2019-10-21 |
| 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 | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V |
| Manufacturer Street | AVE. WASHINGTON 3701, EDIFICIO 4 COLONIA COMPLEJO INDUSTRIAL, LAS AMERICAS |
| Manufacturer City | CHIHUAHUA 31114 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31114 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW DRAINAGE SET |
| Generic Name | CATHETER IRRIGATION |
| Product Code | GBX |
| Date Received | 2019-10-21 |
| Catalog Number | AI-01600 |
| Lot Number | 13F19B0326 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2019-10-21 |