MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. HIGH-FLOW Y-INJECTION PORT; DEVICE, WARMING. BLOOD AND PLASMA

Model Number	Y-INJ
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr was generated under protocol b10009704, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.The sample was received in used conditions without its original packaging.The samples were visually inspected, at a distance of 12? to 24? and normal conditions of illumination.It was observed a cut in the tube.No further functional testing was performed.The root cause could not be determined; however, the most probable root cause is that the product become damaged after it left the manufacturing facilities due to the product is 100% visual inspected.No corrective actions are required since there is no information to suggest that the product was damaged during manufacture.As a preventive action production personnel were notified by quality engineer on as awareness of the defect reported by the customer.
Event or Problem Description
It was reported that failure of disposable tubing occurred during infusion.There was no patient or clinician injury.

• Brand Name: HIGH-FLOW Y-INJECTION PORT
• Common Device Name: DEVICE, WARMING. BLOOD AND PLASMA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15639783
• Report Number: 3012307300-2022-25416
• Device Sequence Number: 5715337
• Product Code: KZL
• UDI-Device Identifier: 30695085403108
• UDI-Public: 30695085403108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK860023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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: 03/02/2022
• Device Model Number: Y-INJ
• Device Catalogue Number: Y-INJ
• Device Lot Number: 3589039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown