FDA Adverse Event Malfunction Summary report: N

STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.

MDR report key: 1052074 · Received May 21, 2008

Report

Report Number: 8030665-2008-00027
Event Type: Malfunction
Date Received: May 21, 2008
Date of Event: April 10, 2008
Report Date: May 21, 2008
Manufacturer: CD REYNOSA/REYNOSA MANUFACTURING
Product Code: KDJ
PMA / PMN Number: K022412
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE HISTORY OT REVIEW; UNABLE TO BE PERFORMED DUE TO LOT NUMBER BEING REPORTED AS UNKNOWN. SAMPLE ANALYSIS: WE RECEIVED THE ACTUAL SAMPLE WITHOUT ORIGINAL PACKAGING. LOT NUMBER WAS NOT AVAILABLE. THE ACTUAL SAMPLE WAS RECEIVED WITHOUT A PATIENT END CONNECTOR. THE STAY SAFE EXTENSION SET HAD ONLY THE CATHETER CONNECTOR END PLUS THE 12" TUBING AND THE WHITE CLAMP. THE PRODUCT COMPLAINT IS CONFIRMED. CORRECTIVE ACTION: THE SUPPLIER HAS BEEN NOTIFIED. FMC REYNOSA WILL CONTINUE TO MONITOR AND TREND.

Description of Event or Problem · 1

AN ELECTRONIC REPORT WAS RECEIVED FROM A RN FROM A PERITONEAL DIALYSIS USER FACILITY. THE RN REPORTED THAT WHEN HER PATIENT WENT TO PUT ON HER EXTENSION SET IN THE ORGANIZER, THE BLUE TIP FELL OFF THE EXTENSION. THE RN WAS CONTACTED FOR ADDITIONAL INFORMATION. IT WAS LEARNED THAT THIS PRODUCT HAD BEEN APPLIED TO THIS PATIENT LESS THAN 6 MONTHS AGO. AS A RESULT OF THIS EVENT, THE RN HAD TO APPLY A NEW EXTENSION SET TO THIS PATIENT. ALSO, THE PATIENT RECEIVED ONE GRAM OF VANCOMYCIN INTRAPERITONEALLY AS A PROPHYLACTIC MEASURE. THE SAMPLE IS AVAILABLE FOR EVALUATION. THE LOT NUMBER IS UNKNOWN. THE PATIENT IS REPORTEDLY FINE WITH NO ILL EFFECT FROM THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	STAY SAFE/LUER LOCK CATHETER EXT. 12 IN.	EXTENSION LINE PERITONEAL DIALYSIS	KDJ	CD REYNOSA/REYNOSA MANUFACTURING	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA