FDA Adverse Event Injury Summary report: N

CURAPLEX

MDR report key: 24710241 · Received March 30, 2026

Report

Report Number
MW5186061
Event Type
Injury
Date Received
March 30, 2026
Date of Event
March 20, 2026
Report Date
March 24, 2026
Manufacturer
BOUND TREE MEDICAL, LLC
Product Code
FOZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CO, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AT APPROXIMATELY 11:40 ON (B)(6) 2026, I INITIATED AN IV ON THE PATIENT FROM CALL NUMBER (B)(6). I UTILIZED THE STANDARD ASEPTIC TECHNIQUE, CLEANED THE SITE PER POLICY, AND OPENED THE PACKAGING OF A CURAPLEX 18G IV CATHETER LOT NUMBER 50713/0484. WHEN I WENT TO REMOVE THE CAP OF THE NEEDLE, IT CAME OFF AS USUAL, BUT IT SOUNDED DIFFERENT. RATHER THAN THE TYPICAL CLICK SOUND IT USUALLY MAKES, IT FELT LIKE THERE WAS A DOUBLE CLICK, OR POTENTIALLY A CRACK OF SOME KIND. I THOROUGHLY EXAMINED THE NEEDLE PRIOR TO VENIPUNCTURE AND THERE WAS NO OBVIOUS ISSUE NOTED TO THE STRUCTURAL INTEGRITY OF THE NEEDLE, HOUSING, OR CATHETER. I PERFORMED THE VENIPUNCTURE WITH APPROPRIATE FLASH IN THE CHAMBER AND ADVANCED THE CATHETER PER STANDARD PROCEDURE. I HELD TAMPONADE (THOUGH THESE CATHETERS SELF-TAMPONADE) AND ATTEMPTED TO ATTACH MY SALINE-PRIMED EXTENSION SET. I WAS UNABLE TO GET THE EXTENSION SET TO ATTACH TO THE CATHETER, AS IT WOULD NOT ENTER THE CATHETER HUB SPACE. UPON FURTHER EXAMINATION, I NOTICED THAT THE CATHETER HUB WAS ENTIRELY OCCLUDED WITH PLASTIC FROM THE NEEDLE. I ATTEMPTED TO REMOVE THE PLASTIC AND THEN IMMEDIATELY REMOVED THE CATHETER FOR THE SAFETY OF THE PATIENT. I APPLIED GAUZE AND PRESSURE TO THE SITE TO CONTROL BLEEDING AND FURTHER EXAMINED THE CATHETER. I HAD ALREADY PLACED THE NEEDLE IN THE SHARPS DISPOSAL, SO I WAS UNABLE TO FULLY EXAMINE IT, BUT UPON INSPECTION OF AN UNUSED NEEDLE DETERMINED THAT THE HOUSING AT THE TIP OF THE NEEDLE HAD SNAPPED OFF, LIKELY WHEN I REMOVED THE CAP. I TOOK PHOTOS OF THE CATHETER FOR REFERENCE, AND THEN DISPOSED OF IT PER POLICY, AS IT WAS BIOHAZARDOUS MATERIAL. I ESTABLISHED ANOTHER PATENT IV WITHOUT INCIDENT AND REPORTED THIS ISSUE TO THE COMPANY OFFICER ON THE CALL AND TO THE OFFICER ASSUMING COMMAND OF THE SHIFT WAS HOLDING OVER FOR A TRAINING. I THEN NOTIFIED EMS LT VIA EMAIL WITH THE PERTINENT DETAILS. THIS STATEMENT PROVIDES SUPPLEMENTAL INFORMATION REQUESTED FOR SAFETY COMMITTEE REVIEW AND FDA NOTIFICATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
785152 CURAPLEX CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BOUND TREE MEDICAL, LLC 1613-86218 50713/0484

Patients

Seq Age Sex Outcome Treatment
1 70 YR Male Required Intervention