MAUDE Adverse Event Report: KENTEC MEDICAL, INC. HUMMI MICRO-DRAW; SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL

Model Number ABG-HM-1

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/07/2023

Event Type  malfunction  

Event Description

Using a hummi micro-draw blood transfer device, for use with split sepctum micro t-connector, to draw labs from an umbilical venous catheter.When switching syringes to collect multiple blood samples, healthcare provider clamped the sample line and pulled syringe off and blood was still slowly coming back out of the line.Healthcare provider quickly put next syringe on and it filled without undoing clamp.Healthcare provider examined clamp with respiratory therapist (rt) and registered nurse (rn).Healthcare providers verified that it was clamped but appeared loose.Healthcare provider then put their waste syringe back into baby and pulled hummi out of line.It was a sharp and had blood in it so healthcare provider put it in the sharps container.Healthcare provider estimates a blood loss of 0.25-0.5mls of blood from event.Baby weighs 4kg and blood loss did not have a significant impact on patient.

• Brand Name: HUMMI MICRO-DRAW
• Type of Device: SYSTEM, BLOOD COLLECTION, VACUUM-ASSISTED, MANUAL
• Manufacturer (Section D): KENTEC MEDICAL, INC.; 17871 fitch; irvine CA 92614
• MDR Report Key: 16223365
• MDR Text Key: 307894956
• Report Number: 16223365
• Device Sequence Number: 1
• Product Code: KST
• 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: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ABG-HM-1
• Device Catalogue Number: ABG-HM-1
• Device Lot Number: 22025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Male
• Patient Weight: 4 KG