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 2020-03-30 for ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB CDC-45854-XP1A manufactured by Arrow International Inc..
[185786978]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185786979]
The customer reports that the dilator tip was shredded after using. The reported defect was detected after 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 | 1036844-2020-00124 |
| MDR Report Key | 9899070 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-16 |
| Device Manufacturer Date | 2019-11-27 |
| 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 | 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 INC. |
| Manufacturer Street | 312 COMMERCE PLACE |
| Manufacturer City | ASHEBORO NC 27203 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27203 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARROW PI CVC KIT: 4-L 8.5 FR X 20 CM AGB |
| Generic Name | CATHETER,INTRAVASCULAR,THERAP |
| Product Code | FOZ |
| Date Received | 2020-03-30 |
| Catalog Number | CDC-45854-XP1A |
| Lot Number | 23F19K0130 |
| 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 | 2020-03-30 |