SECNDRY SET 34IN NDEHP W/EXT HOOK
Received Nov 7, 2015 · Event occurred Aug 14, 2012
Report 9613251-2015-00063 · MDR key 5209467
Device
Product problems
- Failure to Deliver
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH MFR REPORT #9615050-2012-01106 IT WAS NOTED THE MANUFACTURER REPORT # FOR (B)(4) WAS INADVERTENTLY SELECTED INSTEAD OF THE INTENDED (B)(4) MANUFACTURER#.
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED NO FLOW. AN UNSPECIFIED PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO A UNSPECIFIED LOCATION ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED NO FLOW OF SOLUTION. REPORTEDLY, A BULGE WAS NOTED IN THE TUBING OF THE SECONDARY TUBING SET. NO SPECIFIC EVENT DETAILS WERE PROVIDED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED, IF THERE WERE ANY REPORTED ADVERSE PATIENT EFFECTS, DELAYS IN THERAPY CRITICAL TO THIS PATIENT, AND IF MEDICAL INTERVENTIONS WERE REQUIRED.
Additional Manufacturer Narrative
THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. UPON FDA REQUEST, THIS REPORT IS BEING SUBMITTED TO REPORT THE CORRECT MFR NUMBER.
Description of Event or Problem
THE CUSTOMER CONTACT REPORTED NO FLOW. AN UNSPECIFIED PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PUMP. AT AN UNSPECIFIED TIME, THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS CONNECTED TO A UNSPECIFIED LOCATION ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME, THE CUSTOMER CONTACT REPORTED NO FLOW OF SOLUTION. REPORTEDLY, A BULGE WAS NOTED IN THE TUBING OF THE SECONDARY TUBING SET. NO SPECIFIC EVENT DETAILS WERE PROVIDED. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION INCLUDING IF THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED, IF THERE WERE ANY REPORTED ADVERSE PATIENT EFFECTS, DELAYS IN THERAPY CRITICAL TO THIS PATIENT, AND IF MEDICAL INTERVENTIONS WERE REQUIRED.