FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 276023
·
Received April 28, 2000
Report
- Report Number
- 3032312-2000-00003
- Event Type
- Malfunction
- Date Received
- April 28, 2000
- Date of Event
- January 1, 1999
- Manufacturer
- THE KENDALL CO
- Product Code
- MPB
- Removal / Correction Number
- X
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
KENDALL HEALTHCARE RECEIVED MED-WATCH FROM FDA #4002708 ON 3/29/2000. MED-WATCH REPORTS THAT A CUSTOMER (UNK) HAS REPORTED TO THE FDA, THAT 7 CATHETERS HAVE BROKEN AND FAILED AND REQUIRED REPLACEMENT OF ENDS. THREE OF THE CATHETERS WERE IMPLANTED AT ONE HOSP IN 1999. FIVE OF THE SEVEN CATHETERS WERE VAS-CATHS WHICH ARE NOT KENDALL HEALTHCARE PRODUCTS AND TWO WERE QUINTON CATHETERS. TWO CATHETERS WERE INSERTED AT THE (UNK) HOSP IN 1999 AND ONE CATHETER WAS INSERTED ON AN UNKNOWN DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | DIALYSIS CATHETER | MPB | THE KENDALL CO | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |