MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	30822
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	08/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s report of a broken off tip was confirmed.Visual inspection of the set noted the tip of the male luer was broken off.The broken off tip was lodged within one of the two female ports of the stopcock.Visual inspection under magnification of the male luer and stopcock components observed no markings around or obvious damages or issues.Further inspection of the broken luer tip areas observed whitish colored stress markings at the corresponding areas of breakage.This is likely evidence of excess force being applied.Functional testing was not performed due to separation.The root cause of the break is due to an outside force on the male luer as indicated by the observed stress marks at the break site.The root cause of the outside force could not be determined.
Event or Problem Description
This file was created for an unspecified tubing issue in which patient and event information were not provided.Although requested, there is no further patient or event information available.
Additional Manufacturer Narrative
Additional information provided:date of event, description of event or problem, report source, adverse event problem & medical products & therapy dates.
Event or Problem Description
This file was created for an unspecified tubing issue in which patient and event information were not provided.Although requested, there is no further patient or event information available.Updated event information from customer; "the line was found to be leaking during.Upon inspection it was discovered that (the) tip of the line had broken into (to) stopcock".The customer further confirmed that there was no significant delay in care nor any patient harm as a result of this event.

• Brand Name: MICROBORE EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9489470
• Report Number: 9616066-2019-03695
• Device Sequence Number: 1189605
• Product Code: FPA
• UDI-Device Identifier: 07613203011112
• UDI-Public: 7613203011112
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30822
• Device Catalogue Number: 30822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-BD STOPCOCK, THERAPY DATE UNK.; THERAPY DATE 08/29/2019.