MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-03 for CANNON II PLUS REPLACEMENT HUB SET CAR-02800 manufactured by Arrow Intl., Inc..
[3759394]
It was reported that in dialysis, a leak was found from the extension lines of the replacement kit and in turn not allowing the normal dialysis procedure to take place on this male patient. As a result, a new repair kit was opened and used without issue. There was no reported delay, death, or complications to the patient as a result of this occurrence. The replacement kit was used approximately a month prior to the leak.
Patient Sequence No: 1, Text Type: D, B5
[10916301]
Manufacturer control number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1036844-2013-00264 |
| MDR Report Key | 3267113 |
| Report Source | 01,07 |
| Date Received | 2013-08-03 |
| Date of Report | 2013-07-30 |
| Date of Event | 2013-07-29 |
| Date Mfgr Received | 2013-07-30 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-10-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JODY CADD, SR SPECIALIST |
| Manufacturer Street | 2400 BERNVILLE RD |
| Manufacturer City | READING PA 19605 |
| Manufacturer Country | US |
| Manufacturer Postal | 19605 |
| Manufacturer Phone | 6103780131 |
| Manufacturer G1 | ARROW INTL., 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 | 2013-08-03 |
| Catalog Number | CAR-02800 |
| Lot Number | RF2071793 |
| 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 INTL., INC. |
| Manufacturer Address | READING PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-03 |