7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI
Report
- Report Number
- 9617594-2025-00587
- Event Type
- Malfunction
- Date Received
- March 28, 2025
- Date of Event
- February 1, 2025
- Report Date
- March 28, 2025
- Manufacturer
- ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
- Product Code
- FPA
- UDI-DI
- 00887709047204
- PMA / PMN Number
- K100576
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE COMPLAINT OF NOT STAYING TIGHTENED ON ITEM 12517-01 CANNOT BE CONFIRMED. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. LOT HISTORY REVIEW WAS CONDUCTED AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT.
THE EVENT INVOLVED A 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MICROCLAVE¿ CLEAR, PURPLE CLAMP, ROTATING LUER WHERE THE CUSTOMER REPORTED THAT THE EXTENSION SET IS NOT STAYING TIGHTENED OUT OF THE PACKAGE. ADDITIONALLY, THIS OCCURRED TWICE WHERE THE EXTENSION FELL OFF THE IV AND MADE A MESS OF BLOOD AND NORMAL SALINE. THE CUSTOMER STATED THAT THE EVENT OCCURRED SEVERAL TIMES BETWEEN (B)(6) 2025. THE EVENT OCCURRED DURING PATIENT USE; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650540 | 7" (18 CM) APPX 0.31 ML, SMALLBORE PRESSURE INFUSION (400PSIG) EXT SET W/REMV MI | SET, ADMINISTRATION, INTRAVASCULAR | FPA | ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. | 14153219 | 00887709047204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SALINE, ICU MEDICAL, NDC NUMBER 0990-7983-09 |