MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for ARROW RA CATH KIT: 20 GA X 1-3/4" (4.45 CM) ASK-04020-MHS manufactured by Arrow International Inc..
[184498295]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184498296]
The customer reports that the needle separated or "broke off" from the rest of the assembly. The doctor secured the piece of metal protruding from the patient and removed it. The reported defect was detected during use. The patient condition is reported as "fine". There was no patient complication, injury or consequence. Therapy was not delayed/interrupted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00161 |
| MDR Report Key | 9866323 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-05-22 |
| Date Added to Maude | 2020-03-23 |
| 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 | 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 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 RA CATH KIT: 20 GA X 1-3/4" (4.45 CM) |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DQX |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-16 |
| Catalog Number | ASK-04020-MHS |
| Lot Number | 13F19E0500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-23 |