MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2016-02-09 for CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..
[37792632]
(b)(4). No sample will be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[37792633]
It was reported that the color-coded luer hub cracked during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2016-00098 |
| MDR Report Key | 5418784 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2016-02-09 |
| Date of Report | 2016-02-02 |
| Date of Event | 2015-11-01 |
| Date Mfgr Received | 2016-02-02 |
| Device Manufacturer Date | 2014-05-22 |
| Date Added to Maude | 2016-02-09 |
| 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 | JOHN GEORGE |
| Manufacturer Street | 2400 BERNVILLE ROAD |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| Manufacturer Phone | 6103780131 |
| 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 | CANNON II PLUS REPLACEMENT HUB SET |
| Generic Name | CHRONIC HEMODIALYSIS PRODUCTS |
| Product Code | NFK |
| Date Received | 2016-02-09 |
| Catalog Number | CAR-02400 |
| Lot Number | 23F14E1155 |
| ID Number | 00801902031563 |
| Device Expiration Date | 2017-06-30 |
| 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 | 2016-02-09 |