FDA.reportPublic FDA data

MAUDE MDR 5563643

MDR report key
5563643
Report number
1030451-2016-00007
Event key
0
Event type
3
Date of event
2016-03-06
Date received
2016-04-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NICHOLE EARLY
Address
25 HEYWOOD ROAD ARDEN NC 28704 US
Phone
828-828-8283
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MCKESSONKIT: IV 50/CSMEDICAL ACTION INDUSTRIESLRS25-581825-5818216737R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-080

Event Narratives#

N

Patient 1

ON 03/09/2016, MEDICAL ACTION INDUSTRIES (MAI) RECEIVED A COMPLAINT THAT A HEALTHCARE WORKER CUT HER FINGER ON A FRACTURED CHLORAPREP SEPP APPLICATOR DURING THE USE OF MEDICAL ACTION INDUSTRIES MANUFACTURED, MCKESSON-BRANDED IV START KIT (REF: 25-5818). THE COMPLAINT REPORT INDICATED THAT THE END-USER HAD THE COMPONENT IN THEIR POSSESSION. CAREFUSION IS THE MANUFACTURER OF THE CHLORAPREP SEPP ((B)(4)). CAREFUSION WAS NOTIFIED OF THE INCIDENT AND PROVIDED THE END-USER CONTACT INFORMATION TO OBTAIN THE INVOLVED COMPONENT. A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO CAREFUSION ((B)(4)) TO INVESTIGATE AND RESPOND WITH APPROPRIATE INVESTIGATION DETAILS. CAREFUSION STATED THAT THEY WERE UNABLE TO OBTAIN RESPONSE FROM THE END-USER REGARDING RETRIEVAL OF THE COMPONENT FOR INVESTIGATION. MEDICAL ACTION INDUSTRIES ALSO ATTEMPTED COMMUNICATION TO RETRIEVE THE COMPONENT. ALL ATTEMPTS TO OBTAIN CUSTOMER SAMPLE HAVE BEEN UNSUCCESSFUL. CAREFUSION IS GOING TO EVALUATE THE COMPLAINT AND RESPOND UPON CONCLUSION OF THEIR INVESTIGATION; HOWEVER, THEY INDICATED THIS INVESTIGATION WOULD BE LIMITED WITHOUT THE COMPONENT FOR EVALUATION. MEDICAL ACTION INDUSTRIES USES THIS SAME COMPONENT IN VARIOUS MANUFACTURED CONVENIENCE KITS. AT THE TIME OF COMPLAINT RECEIPT, MAI DID NOT HAVE ANY OF THE SAME COMPONENT LOT NUMBER ONSITE TO INVESTIGATE. WE CAN CONFIRM THAT A REVIEW OF OUR COMPLAINT DATABASE REFLECTS NO OTHER COMPLAINTS RECEIVED ON THIS SAME KIT LOT NUMBER OR ON THE SAME COMPONENT LOT NUMBER. THEREFORE, AT THIS TIME THIS INSTANCE APPEARS TO BE ISOLATED AND THE ROOT CAUSE UNKNOWN. MAI WILL CONTINUE TO WATCH FOR ADDITIONAL COMPLAINTS REGARDING THIS COMPONENT.

D

Patient 1

A MCKESSON BRANDED IV START CONVENIENCE KIT, REF: 25-5818, IS MANUFACTURED BY MEDICAL ACTION INDUSTRIES, AN (B)(4). THIS KIT CONTAINS COMPONENT, CHLORAPREP SEPP 0.67 APPLICATOR, (B)(4), WHICH IS MANUFACTURED BY CAREFUSION. ON 03/09/2016, MAI RECEIVED A COMPLAINT FROM MCKESSON WHICH STATED THAT END-USER FACILITY (B)(4) HAD REPORTED AN EMPLOYEE INJURY WHEREBY THE CHLORAPREP SEPP APPLICATOR FRACTURED AND CUT STAFF MEMBER'S FINGER UPON ATTEMPTED USE. MAI VERIFIED THAT THE CUSTOMER REPORTED THAT ONLY INITIAL FIRST AID CLEANING WAS REQUIRED AND NO FURTHER TREATMENT, INTERVENTION OR HOSPITALIZATION WAS NECESSARY TO THE STAFF MEMBER.