FDA Adverse Event Malfunction Summary report: N

CHEMFORT

MDR report key: 24243859 · Received February 3, 2026

Report

Report Number
9611423-2026-00006
Event Type
Malfunction
Date Received
February 3, 2026
Date of Event
December 20, 2025
Report Date
February 2, 2025
Manufacturer
SIMPLIVIA HEALTHCARE LTD.
Product Code
ONB
UDI-DI
37290115921435
PMA / PMN Number
K192866
Product Problem
Yes
Report Source
Manufacturer report
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

CUSTOMER:(B)(4), (B)(6). (B)(6) 2025 WHEN DID THE FAILURE OCCUR: DURING THERAPY REASON OF COMPLAINT: WE HAD A PATIENT REPORT THAT HER 5FU PUMP WAS LEAKING AT THE CONNECTION SITE TO HER PORT. THE ORANGE PIECE CAME APART. DRUG SPILLED ON PATIENT AND BLOOD GOT INTO THE LINE. THE PATIENT WENT TO THE ER, AND THE ER SNAPPED IT BACK INTO PLACE, BUT THE PUMP HAD 47.9 ML REMAINING (~16 HOURS) AND WAS NOT CONTINUED. THE ORDER NUMBER IS X. THE PATIENT CAME BACK AT 11:45 TODAY TO GET A NEW CASSETTE ATTACHED FOR THE REMAINING DRUG PER DOCTOR'S REQUEST. CHARGE RN IS SUBMITTING AN INCIDENT AND WILL PROVIDE THE INCIDENT NUMBER WHEN SHE DOES SO. -FROM GS, PHARMD. MEDICATION COMPOUNDED BY PHARMACY TECH, ADMINISTERED BY RN FIRST CONTACT TO END CUSTOMER: B. BRAUN ADDITIONAL PATIENT INFORMATION: SPOKE WITH PT AFTER RECEIVING UPDATE FROM MD RE: PORT AND CONT 5FU ISSUES. PT REPORTS THAT APPROX 1930 SHE SAT DOWN ON COUCH AND HELD THE INFUSION TUBING SO SHE WOULD NOT SIT ON. SHE NOTICED AT THAT TIME THAT SHE HAD A FEW DROPS OF BLOOD AND CLEAR FLUID (5FU) IN HER HAND. PT STOPPED PUMP AND WASHED HANDS. PT HAD APPROX 13-14 HRS OF THE INFUSION LEFT. IT WAS ALSO NOTED THAT SHE HAD A SMALL WET AREA ON HER JACKET. PT ASSESSED TUBING AND NOTED THAT BLOOD HAD BACKFLOWED INTO THE PORT NEEDLE TUBING AND THE LEAKING WAS COMING FROM WHERE THE PIGTAIL TUBING OF PORT CONNECTED TO THE 5FU TUBING. PT WAS INSTRUCTED TO GO TO ER BY MD. PT WRAPPED PAPER TOWEL AROUND THE CONNECTION TO STOP THE LEAKING AND WHEN ARRIVED TO ER, SHE UNWRAPPED THE PAPER RESPONSE EXPECTED BY: CUSTOMER; COMPLAINT RECEIVER PRODUCTS RELATED TO COMPLAINT. ARTICLE / BATCH: CADD PUMP EXTENSION SET/N/A MANUFACTURER OF DRUG: FRESENIUS KABI ARTICLE / BATCH: FLUOROURACIL 5020 MG/138 ML NS, EXP2/27/6134956 OTHERS: ARTICLE / BATCH: CADD RESERVOIR/N/A (B)(6) 2025 PATIENT INJURY UNKNOWN PATIENT HARM: CHEMO SPILLED ON PATIENT, TX RESTARTED PRODUCT LIABILITY: UNKNOWN NO SAMPLE ON (B)(4) REGISTRATION FORM CUSTOMER COMPLAINT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
305472 CHEMFORT ONGUARD SYRINGE ADAPTOR LOCK ONB SIMPLIVIA HEALTHCARE LTD. UBY585 37290115921435

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown