FDA Adverse Event
Malfunction
Summary report: N
2-L HUB CONNECT ASSY REPLACEMENT SET
MDR report key: 2150505
·
Received June 22, 2011
Report
- Report Number
- 1036844-2011-00203
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- May 30, 2011
- Report Date
- June 21, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- NFK
- PMA / PMN Number
- K020430
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FOLLOW-UP REPORT WILL BE FILED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM CHRONIC RENAL FAILURE. THE PATIENT HAD THE REPAIR KIT FITTED LATE LAST YEAR IN THE LEFT SUBCLAVIAN VEIN AND AFTER ONLY 5 MONTHS OF USE, DURING DIALYSIS IN THE RENAL UNIT, THE ARTERIAL AND VENOUS HUBS CRACKED. THE UNIT WAS REMOVED AND REPLACED WITHOUT ISSUE. THERE WAS NO REPORTED DELAY, DEATH OR COMPLICATIONS TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2-L HUB CONNECT ASSY REPLACEMENT SET | CHRONIC HEMODIALYSIS CATHETER PRODUCTS | NFK | ARROW INTL., INC. | RF8129139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |