MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET; DEVICE, WARMING. BLOOD AND PLASMA

Catalog Number	D-300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak on the y-connector of a level 1® disposable normothermic iv administration set during intravenous and blood transfusion.The incident occurred immediately upon use.It was reported that there was no patient injury and no medical intervention required.
Additional Manufacturer Narrative
One y-connector of a level 1® disposable normothermic iv administration set was returned for analysis in unused condition.The sample was visually inspected at a distance of 12" to 24".The returned sample was connected to an h-1200 hotline fluid warmer for functional testing.The sample leaked at the joint of the 3 "y" connector.A review of the manufacturing and inspection processes was conducted and was considered adequate and correct.The failure mode was leaking.The root cause was identified as a lack of robust and repeatable adhesive dispensing to achieve the desired adhesive depth and that the components were potentially not tested for leaks.See mfr: 3012307300-2017-02640, 3012307300-2017-02642.

• Brand Name: LEVEL 1® DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7137835
• Report Number: 3012307300-2017-02641
• Device Sequence Number: 13739558
• Product Code: KZL
• UDI-Device Identifier: 20695085430008
• UDI-Public: 20695085430008
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: D-300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 01/11/2018
• Initial Report FDA Received Date: 12/21/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1