MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-06-03 for CANNON II PLUS REPLACEMENT HUB SET CAR-03600 manufactured by Arrow International Inc..
[4517336]
It was reported that the patient involved was a (b)(6) male with a history of renal failure, catheterized since 2009, and on his third repair kit. In the renal unit during dialysis, the hub of the catheter placed in the patient's right internal jugular vein was found leaking at the hub. As a result, a new repair kit was successfully used to solve the issue. There was no reported delay, death, or complications to the patient as a result of this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[11966205]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2014-00249 |
| MDR Report Key | 3922241 |
| Report Source | 01,07 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-05-22 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2014-05-22 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2014-07-21 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODY CADD, SR. SPECIALIST |
| 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 PL. |
| 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 CATHETER PRODUCTS |
| Product Code | NFK |
| Date Received | 2014-06-03 |
| Catalog Number | CAR-03600 |
| Lot Number | FR1045472 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-03 |