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 2020-03-18 for ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM CV-15142-UF manufactured by Arrow International Inc..
[184071481]
Qn#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184071482]
Customer reported that when the nurse in charge of removing the dressing covering the catheter, she noticed that the arterial extension line (red) was disconnected from the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006425876-2020-00243 |
| MDR Report Key | 9848586 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-10-11 |
| Date Added to Maude | 2020-03-18 |
| 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 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 | 3 |
| Brand Name | ARROW HEMODIALYSIS SET: 2-LUMEN 14 FR X 20 CM |
| Generic Name | CATHETER, HEMODIALYSIS, NON-I |
| Product Code | MPB |
| Date Received | 2020-03-18 |
| Catalog Number | CV-15142-UF |
| Lot Number | 71F18K0549 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-03-18 |