HIGH FLOW TRF SET
Received Mar 8, 2013 · Event occurred Nov 1, 2012
Report 9613251-2013-00062 · MDR key 3008335
Device
Product problems
- Difficult to Insert
Patient
31 YR
- Injury
Narrative
Description of Event or Problem
GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF DIFFICULTY INSERTING THE PIERCING PIN OF THE TUBING SETS INTO ADMINISTRATIVE PORT OF SOLUTION CONTAINERS; SUBSEQUENTLY, A HAND INJURY WAS REPORTED. THE TUBING SETS WERE BEING USED TO TRANSFER UNSPECIFIED VOLUMES OF AMINOSYN FROM SOLUTION CONTAINERS INTO UNSPECIFIED CONTAINERS. THE CUSTOMER CONTACT REPORTED THAT DURING THE DURATION OF AN UNSPECIFIED LENGTH OF TIME, A PHARMACY TECHNICIAN GRASPED AN UNSPECIFIED PORT OF THE AMINOSYN CONTAINERS AND INSERTED THE PIERCING PIN OF THE TUBING SETS WITH A TWISTING MOTION INTO THE PORT OF THE SOLUTION CONTAINERS. AT AN UNSPECIFIED TIME, THE PHARMACY TECHNICIAN REPORTED A HAND INJURY DUE TO THE DIFFICULTY INSERTING THE PIERCING PIN OF THE TUBING SETS INTO ADMINISTRATIVE PORT OF SOLUTION CONTAINERS. IT WAS REPORTED THAT THE PHARMACY TECHNICIAN UNDERWENT TWELVE SESSIONS OF OCCUPATIONAL THERAPY ON UNSPECIFIED DATES DURING THE MONTH OF (B)(6). THE CUSTOMER CONTACT REPORTED THAT THE OCCUPATIONAL THERAPY DID NOT PROVIDE SATISFACTORY RELIEF. ON (B)(6) /2013, THE PHARMACY TECHNICIAN RECEIVED A HYDROCORTISONE INJECTION AT AN UNSPECIFIED LOCATION ON THE LEFT HAND. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
THE CUSTOMER CONTACT INDICATED THAT THE DEVICES WERE DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.