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 2016-11-07 for CANNON II PLUS REPLACEMENT HUB SET CAR-02400 manufactured by Arrow International Inc..
[59343492]
(b)(4). This report is for the second in a series of two consecutive product problems with the same patient. The first issue has been reported under mdr # 1036844-2016-00558.
Patient Sequence No: 1, Text Type: N, H10
[59343493]
This is the second complaint involving the same patient. It was reported that in nephrology, the user successfully inserted a chronic hemodialysis catheter into the patient's jugular. After six months in use, the nurse found leakage when the patient had hemodialysis treatment. As a result, new extension tube was replaced, however, after two hemodialysis treatments, the extension tube cracked again. Doctor replaced another new extension tube. A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence. The patient involved was a (b)(6) yr/old male, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[61256589]
(b)(4). Device evaluation: complaint verification testing could not be performed because no sample was returned for analysis. A device history record review was performed and it did not reveal any manufacturing related issues. The probable cause of a leak in the connector assembly could not be determined based upon the information provided and without a sample. No further action will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2016-00559 |
| MDR Report Key | 6082174 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-07 |
| Date of Report | 2016-10-12 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2016-10-12 |
| Device Manufacturer Date | 2014-06-24 |
| Date Added to Maude | 2016-11-07 |
| 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 | 2016-11-07 |
| Catalog Number | CAR-02400 |
| Lot Number | 23F14F1348 |
| ID Number | 00801902031563 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-11-07 |