inforMED
InjuryFPK

HIGH FLOW TRF SET

Received Mar 8, 2013 · Event occurred Jan 1, 2013

Report 9613251-2013-00061 · MDR key 3008334

Device

Generic name

80fpk

Manufacturer

Hospira, Ltd

Model number

NA

Catalog number

15435

Lot number

UNKKZ

Product problems

  • Difficult to Insert

Patient

50 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 SOLUTION FROM UNSPECIFIED CONTAINERS TO FLEXIBLE SOLUTIONS CONTAINERS. THE CUSTOMER CONTACT REPORTED THAT DURING A DURATION OF AN UNSPECIFIED LENGTH OF TIME, A PHARMACY TECHNICIAN GRASPED THE ADMINISTRATIVE PORT OF UNSPECIFIED SOLUTION 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. THE CUSTOMER CONTACT REPORTED THAT , ON AN UNSPECIFIED DATE, THE PT UNDERWENT A SURGICAL PROCEDURE TO RELEASE A TENDON IN THE PHARMACY TECHNICIAN'S LEFT RIGHT FINGER. IT WAS REPORTED THAT THE PHARMACY TECHNICIAN RETURNED TO WORK ON AN UNSPECIFIED DATE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE CUSTOMER CONTACT INDICATED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.