MAUDE Adverse Event Report: HUMMINGBIRD MED DEVICES INC SPLIT SEPTUM MICRO T-CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number NMT8046

Device Problems Fluid/Blood Leak (1250); Component Missing (2306); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

After change of shift, collection of fluid & blood found under baby¿s head and shoulders.Picc (peripherally inserted central catheter) line red lumen found to be leaking back through the t-connector, where the rubber stopper usually is, which was now missing.Most likely dislodged during a blood draw.Patient has a 2.6fr dl (double lumen) picc in upper right extremity.Red lumen is used for lab draws through the rubber stopper on the t-connector.Line was accessed for a lab draw earlier that morning at 416 per chart by night nurse.Blood noticed at 0732 by day nurse after report.Enough blood and fluid to soak through z-flo cover around both sides of the head and onto blankets through to the bottom blanket.Clots found in hair.Ebl (estimated blood loss) 10-15ml.Rubber stopper found on cover near head.Infant remained stable per vs (vital signs) and assessment.T-connector replaced, and provider notified immediately.Faulty t-connector saved and will be given to apcm (assistant patient care manager).Provider team to decide if necessary to obtain additional lab work and/or transfuse infant.There was no harm in this event.This is not a recurring issue.Event has been logged for tracking purposes.Supply chain will continue to monitor issues related to this item.There has not been an official recall for the item from the manufacturer.Information on the defect will be forwarded on to the manufacturer to file a quality report.

• Brand Name: SPLIT SEPTUM MICRO T-CONNECTOR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HUMMINGBIRD MED DEVICES INC; 1283 elger bay road ste d; camano island WA 98282
• MDR Report Key: 13117512
• MDR Text Key: 282971361
• Report Number: 13117512
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NMT8046
• Device Lot Number: 21210
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2021
• Date Report to Manufacturer: 12/30/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA
• Patient Sex: Male