MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET T-CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MX453
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Event or Problem Description
It was reported that a medexultra small bore extension set t-connector was cracked and leaking.The fault was noticed immediately upon use.No injury was reported.

• Brand Name: MEDEX¿ ULTRA¿ SMALL BORE EXTENSION SET T-CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6690851
• Report Number: 3012307300-2017-01419
• Device Sequence Number: 46470
• Product Code: FPA
• UDI-Device Identifier: 10351688507259
• UDI-Public: 10351688507259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K790408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/06/2017

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: No Information
• Device Catalogue Number: MX453
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1