CAPILLARY CAPS
Received Dec 9, 2014 · Event occurred Oct 19, 2014
Report 1217157-2014-00188 · MDR key 4309718
Device
Generic name
Capillary Caps
Manufacturer
Siemens Healthcare DiagnosticsCatalog number
08685906
Lot number
08685906
Product problems
- Material Too Rigid or Stiff
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: SIEMENS INVESTIGATION IDENTIFIED THAT A MATERIAL CHANGE MADE BY THE SUPPLIER HAS RESULTED IN CAPILLARY CAPS THAT ARE MORE DIFFICULT TO APPLY TO THE CAPILLARIES. AN URGENT FIELD SAFETY NOTICE #32320 WAS SENT BY E-MAIL TO ALL AFFECTED SIEMENS HEALTHCARE DIAGNOSTICS REGIONAL OFFICES ON JANUARY 22, 2015 BOTH IN THE UNITED STATES AND ELSEWHERE FOR COMMUNICATION WITH AFFECTED CUSTOMERS. PLEASE NOTE: THESE CAPILLARY CAPS ARE AN "OFF THE SHELF" ITEM. SIEMENS PURCHASES THEM FROM A DISTRIBUTOR AND REPACKAGES THEM.
Description of Event or Problem
CUSTOMER REPORTED THAT CAPILLARY CAPS WERE VERY STIFF. CUSTOMER ALSO REPORTED THAT THEY WERE USING THESE CAPS IN COMBINATION WITH SIEMENS 100 & 140 UL GLASS CAPILLARIES. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.
Additional Manufacturer Narrative
THIS EVENT IS UNDER INVESTIGATION. THE CAUSE FOR THE EVENT IS UNKNOWN.
Remedial action
- Recall