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..
[135709253]
Infant with umbilical artery catheter in place attached to a smiths medical closed blood sample kit. 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 lab work. When aspirating the blood, air was noted to enter the syringe which affected the sample. Registered nurse reported there appeared to be air trapped under the port. There is concern 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. If air enters the line, the tubing has to be replaced which includes discarding the infant's blood that has been pulled back into the closed system. This discard amount can be significant due to the premature infant's size. In this case, the air was pulsed out of the tubing using sterile technique and then reattached to the infant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8324898 |
| MDR Report Key | 8324898 |
| Date Received | 2019-02-11 |
| Date of Report | 2019-02-04 |
| Date of Event | 2019-01-13 |
| 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 |