MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-15 for ARROW VASCULAR UNKNOWN manufactured by Arrow International Inc..
[145227504]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[145227505]
"i am investigating an incident where the tip of a 9 fr tissue dilator used for internal jugular cannulation fractured within a patient. " very limited information received on this complaint. The product code and lot number are unknown. The condition of the patient is also unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2019-00375 |
| MDR Report Key | 8612176 |
| Date Received | 2019-05-15 |
| Date of Report | 2019-04-19 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-06-05 |
| Date Added to Maude | 2019-05-15 |
| 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 | KEELY MCKINLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334889 |
| 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 | 0 |
| Brand Name | ARROW VASCULAR UNKNOWN |
| Product Code | GCC |
| Date Received | 2019-05-15 |
| Catalog Number | VASCULAR UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-05-15 |