MAUDE Adverse Event Report: CAREFUSION SMALLBORE EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	10373772
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided but patient was a child.
Event or Problem Description
The customer reported that patients coming from the er to the pediatric intermediate medical care unit had extension sets that would crack and leak at the male component under the spin collar at the connection to the iv catheter.This has happened 5 times in the last 2-3 weeks.At times, peripheral ivs had to be replaced.
Additional Manufacturer Narrative
The customer¿s report of a cracked and leaked extension set at the male luer component was not confirmed.Visual inspection of the set noted no damage or any anomalies.Functional and pressure testing resulted in the set flowing freely and showed no signs of leaking while the tubing was manipulated at each engagement.The root cause was not identified.
Event or Problem Description
The customer reported that patients coming from the er to the pediatric intermediate medical care unit had extension sets that would crack and leak at the male component under the spin collar at the connection to the iv catheter.This has happened 5 times in the last 2-3 weeks.At times, peripheral ivs had to be replaced.

• Brand Name: SMALLBORE EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8347802
• Report Number: 9616066-2019-00445
• Device Sequence Number: 1867121
• Product Code: FPA
• UDI-Device Identifier: 10885403234194
• UDI-Public: 10885403234194
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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 Expiration Date: 07/07/2021
• Device Model Number: 10373772
• Device Catalogue Number: 10373772
• Device Lot Number: 18075290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/18/2019
• Supplement Report FDA Received Date: 06/17/2019
• 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: IV CATHETER, THERAPY DATE UNK