INSYTE-N
Received Jul 16, 2026 · Event occurred Jul 1, 2026
Report 8041187-2026-00064 · MDR key 25847187
Device
Generic name
Intravascular Catheter
Manufacturer
Becton Dickinson Medical (singapore)Catalog number
381211
Lot number
2140262
Product problems
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
"IT WAS REPORTED THAT ON (b)(6) 2026, IN THE PEDIATRIC EMERGENCY DEPARTMENT, WHILE PERFORMING A BLOOD CULTURE, BLOOD DID NOT FLOW BACK UP THE CATHETER AND LEAKED ONTO THE PATIENT¿S BED OR STRETCHER. SEVERAL CATHETERS EXHIBITED THE SAME DEFECT, AND 29 DEVICES FROM THE SAME LOT WERE QUARANTINED. THE INCIDENT RESULTED IN COMPROMISED SAMPLE QUALITY BUT HAD NO CONSEQUENCES FOR THE PATIENT. CATHETERS FROM ANOTHER SUPPLIER WERE USED TO CONTINUE PATIENT CARE.THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT RETAINED, BUT ONE OR MORE SAMPLES FROM THE SAME BATCH ARE AVAILABLE AT THE PHARMACY. TO RETRIEVE THEM, PLEASE CONTACT US BY EMAIL AT THE FOLLOWING ADDRESS: (b)(6) AFTERA PROCESSING PERIOD FOR PREPARING THE PACKAGE (MINIMUM 3 BUSINESS DAYS), IT CAN BE PICKED UP AT THE BETWEEN 2:00 P.M. AND 5:00 P.M.: (b)(6).
Additional Manufacturer Narrative
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.