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 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" ASK-15703-PHH manufactured by Arrow International Inc..
[184498467]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184498468]
The customer reports: the user saw the needle under ultrasound, but could not advance the wire. Resistance was felt as they tried to advance and when pulled out the wire was sheared. Therapy was reported to be delayed/interrupted. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680794-2020-00169 |
| MDR Report Key | 9866502 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-10 |
| 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 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" |
| Generic Name | CATHETER,INTRAVASCULAR,THERAP |
| Product Code | FOZ |
| Date Received | 2020-03-23 |
| Catalog Number | ASK-15703-PHH |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-03-23 |