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

Model Number	10015817
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
It was reported that there was a tubing crack with a leak.A quadfuse extension set was in use on an umbilical venous catheter, when a crack with a leak was observed at the "nad." it was noted that the tubing was clamped off and the quadfuse extension set was replaced.The event occurred on a pediatric unit.There was no patient harm.Although requested, no additional patient information was provided.
Event or Problem Description
It was reported that there was a tubing crack with a leak.A quadfuse extension set was in use on an umbilical venous catheter, when a crack with a leak was observed at the "nad." it was noted that the tubing was clamped off and the quadfuse extension set was replaced.The event occurred on a pediatric unit.There was no patient harm.Although requested, no additional patient information was provided.
Additional Manufacturer Narrative
Correction: omit (3)white caps from d.11 on initial report.The customer's report that the tubing set cracked and leaked was confirmed.There were multiple cracks along the side of the set's female luer and a leak from the crack.Although damage was observed, functional testing was performed.Fluid from a lab syringe was pushed through.The fluid leaked from the crack.No other leak was observed.The root cause of the crack was identified as a result of internal stresses created in the luer during the manufacturing process that make it more susceptible to chemical/mechanical attacks.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10005074
• Report Number: 9616066-2020-01509
• Device Sequence Number: 19684510
• Product Code: FPA
• UDI-Device Identifier: 10885403234057
• UDI-Public: 10885403234057
• 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: company representative,other
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 10015817
• Device Catalogue Number: 10015817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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: 8015,PRI TUBING,8100,(3)WHITE CAPS,TD (B)(6) 2020.; 8015,PRI TUBING,8100,(3)WHITE CAPS,TD (B)(6) 2020