MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. MEDEX¿ MICRO BORE T-CONNECTORS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	BBF26
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hypoxia (1918); Neonatal Deformities (1974)
Date of Event	08/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a drop in oxygen saturation following use of a medex¿ micro bore t-connector.A critically ill patient was admitted at birth diagnosed with severe heart disease, most notably, no identifiable right ventricular cavity.Medication was being infused into the patient to maintain the patency of the ductus arteriosus.The ductus arteriosus is a blood vessel connecting the main pulmonary artery to the proximal descending aorta.Shortly after admission, the patient was noted to have a drop in oxygen saturation from the low 90s down to the high 70s.Careful inspection of the product noted a drop of fluid below the hub of the connector.The product was changed and the patient's oxygen saturation increased back to 94.The patient stabilized.

• Brand Name: MEDEX¿ MICRO BORE T-CONNECTORS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL, ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6926945
• Report Number: 3012307300-2017-02160
• Device Sequence Number: 1312930
• Product Code: FPA
• UDI-Device Identifier: 10351688512017
• UDI-Public: 10351688512017
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K841882
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2017

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: Health Professional
• Device Expiration Date: 06/05/2020
• Device Catalogue Number: BBF26
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 10/07/2017
• 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
• Patient Age: 3 DA
• Patient Weight: 3