MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES; TUBING, FLUID DELIVERY

Catalog Number	MX448HL60
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	02/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One infusion extension set was returned for evaluation.Sample underwent functional testing to detect for leakage.No leakage was observed, therefore customer reported complaint was not confirmed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
Event or Problem Description
Information was received that while a smiths medical infusion extension set was in use in the nicu, it was noted to be leaking at the connection.It was noted to be about 8 cm x 10 cm area.A piv was placed, as well as labs drawn for complete blood count.Hematocrit was reported to have dropped from 42 to 30, and red blood cells were ordered to be transfused.The pharmacy was notified to send stat total parental nutrition for piv.

• Brand Name: SMITHS MEDICAL MEDEX INFUSION EXTENSION SETS AND DISPOSABLES
• Common Device Name: TUBING, FLUID DELIVERY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8601171
• Report Number: 3012307300-2019-02584
• Device Sequence Number: 2180888
• Product Code: FPK
• UDI-Device Identifier: 10351688507426
• UDI-Public: 10351688507426
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: MX448HL60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention