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 2020-03-30 for ARROW PSI KIT: 8.5 FR AJ-09801 manufactured by Arrow International Inc..
[185494126]
(b)(4). Preliminary evaluation of the returned device indicates a sterility issue.
Patient Sequence No: 1, Text Type: N, H10
[185494127]
It was reported that when the user tried to open the kit, that is, began to peel off the tyvek, the tray got broken at the adhered surface to the tyvek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00176 |
| MDR Report Key | 9897069 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-03-04 |
| Date Added to Maude | 2020-03-30 |
| 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 | 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 INTERNATIONAL DE MEXICO S.A. DE C.V. |
| Manufacturer Street | AVE. WASHINGTON 3701 COLONIA PANAMERICANA, CHIHUAHUA |
| Manufacturer City | CHIHUAHUA 31200 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW PSI KIT: 8.5 FR |
| Generic Name | INTRODUCER CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-01-13 |
| Catalog Number | AJ-09801 |
| Lot Number | 13F19C0058 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |