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 2016-06-23 for CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..
[48017347]
(b)(4). No sample will be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[48017348]
It was reported in (b)(6) 2016, a chronic hemodialysis catheter was successfully placed into the jugular vein of a female patient weighing (b)(6). The patient had hemodialysis treatment at a different hospital. When the hemodialysis was done at the end of (b)(6), there was a bubble in the hemodialysis pipeline and the device alarmed. The physician inspected and found a crack in the luer-lock cap. The physician replaced with a new extension tube for continued treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1036844-2016-00335 |
| MDR Report Key | 5744586 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-05-20 |
| Date Mfgr Received | 2016-06-15 |
| Device Manufacturer Date | 2014-06-24 |
| Date Added to Maude | 2016-06-23 |
| 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 | JAMIE HARTZ |
| Manufacturer Street | 2400 BERNVILLE ROAD |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| 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 | 2016-06-23 |
| Catalog Number | CAR-02400 |
| Lot Number | 23F14F1348 |
| ID Number | 00801902031563 |
| Device Expiration Date | 2017-07-31 |
| 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 | 2016-06-23 |