MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM MX4133 manufactured by Smiths Medical Asd, Inc.
[135709617]
Infant with umbilical artery catheter in place attached to smiths medical kids kit adapter. This adapter is attached to tubing for blood pressure monitoring and blood collection. Concern noted during blood collection. Blood was pulled back into the closed system tubing to allow for a specific amount of waste before aspirating blood from the port for labwork. When aspirating the blood, air was also noted to enter the syringe which affected the sample. Staff are concerned that air entered the line via the kid's kit needleless port device. It was reported the correct procedure for collecting the blood sample was followed. The syringe was appropriately attached to the blunt cannula and the blunt cannula was inserted into the kid's kit port. Due to the air entering the line, the tubing had to be replaced which then requires discarding the infant's blood that has been pulled back into the closed system. This discarded amount can be significant due to the size of the infant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8324920 |
| MDR Report Key | 8324920 |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-04 |
| Date of Event | 2018-10-29 |
| Report Date | 2019-02-04 |
| Date Reported to FDA | 2019-02-04 |
| Date Reported to Mfgr | 2019-02-11 |
| Date Added to Maude | 2019-02-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX KIDS KIT CLOSED BLOOD SAMPLING SYSTEM |
| Generic Name | ARTERIAL BLOOD SAMPLING KIT |
| Product Code | CBT |
| Date Received | 2019-02-11 |
| Catalog Number | MX4133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Manufacturer Address | 201 WEST QUEEN ST. SOUTHINGTON CT 06489 US 06489 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-11 |