MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-24 for ARROW MULTI-LUMEN CVC KIT: 3-L 7FR X 8" ASK-45703-VAMCP manufactured by Arrow International Inc..
[184658312]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184658313]
The customer reports that when they opened a kit they realized it was a single lumen and not a three lumen catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2020-00116 |
| MDR Report Key | 9871703 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-11-26 |
| Date Added to Maude | 2020-03-24 |
| 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 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 MULTI-LUMEN CVC KIT: 3-L 7FR X 8" |
| Generic Name | CATHETER,INTRAVASCULAR,THERAP |
| Product Code | FOZ |
| Date Received | 2020-03-24 |
| Catalog Number | ASK-45703-VAMCP |
| Lot Number | 23F19K0211 |
| 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 | 2020-03-24 |