inforMED
MalfunctionKYZ

DOVER

Received Jul 2, 2026 · Event occurred Jun 12, 2026

Report 25689699 · MDR key 25689699

Device

Generic name

Syringe, Irrigating (non Dental)

Manufacturer

Cardinal Health

Model number

68000

Catalog number

68000

Lot number

2515709964

Patient

Not reported

  • Hemorrhage/Blood Loss/Bleeding
  • Foreign Body In Patient

Narrative

Description of Event or Problem

ADULT MALE PATIENT PRESENTED FOR OUTPATIENT RECTAL MRI. TWO, 60 ML PISTON SYRINGES WERE PREPARED WITH CONTRAST AND CAPPED PRIOR TO THE EXAM. THE RADIOLOGIST WAS UNAWARE OF THE SYRINGES BEING CAPPED AND DID NOT SEE THE CLEAR (NO COLOR) CAPS PRIOR TO INJECTION. UPON REVIEW OF THE IMAGES FOR ANGULATION, IT WAS NOTED THAT THERE WAS AN ARTIFACT. ARTIFACTS RESEMBLED THE CAPS FROM THE SYRINGES. THE CLEAR SYRINGE CAPS WERE LOST IN THE PATIENT¿S REMNANT RECTUM WHEN RECTAL CONTRAST WAS INJECTED. THE SURGICAL TEAM WAS UNABLE TO RETRIEVE THE CAPS MANUALLY DUE TO STRICTURE. THE PATIENT WAS SENT FOR SIGMOIDOSCOPY. A FOREIGN BODY WAS FOUND IN THE RECTUM. REMOVAL OF TWO SYRINGE CAPS WAS ACCOMPLISHED WITH A RAT-TOOTHED FORCEPS. A DIFFUSE AREA OF FRIABLE MUCOSA WITH SPONTANEOUS BLEEDING WAS FOUND FROM 0 TO 10 CM PROXIMAL TO THE ANUS.

Description of Event or Problem

51 YO MALE PATIENT WITH PMH OF STAGE IV RECTAL CANCER PRESENTED FOR OUTPATIENT RECTAL MRI. TWO, 60 ML PISTON SYRINGES WERE PREPARED WITH CONTRAST AND CAPPED PRIOR TO THE EXAM. THE RADIOLOGIST WAS UNAWARE OF THE SYRINGES BEING CAPPED AND DID NOT SEE THE CLEAR (NO COLOR) CAPS PRIOR TO INJECTION. UPON REVIEW OF THE IMAGES FOR ANGULATION, IT WAS NOTED THAT THERE WAS AN ARTIFACT. ARTIFACTS RESEMBLED THE CAPS FROM THE SYRINGES. THE CLEAR SYRINGE CAPS WERE LOST IN THE PATIENT¿S REMNANT RECTUM WHEN RECTAL CONTRAST WAS INJECTED. THE SURGICAL TEAM WAS UNABLE TO RETRIEVE THE CAPS MANUALLY DUE TO STRICTURE. THE PATIENT WAS SENT FOR SIGMOIDOSCOPY. A FOREIGN BODY WAS FOUND IN THE RECTUM. REMOVAL OF TWO SYRINGE CAPS WAS ACCOMPLISHED WITH A RAT-TOOTHED FORCEPS. A DIFFUSE AREA OF FRIABLE MUCOSA WITH SPONTANEOUS BLEEDING WAS FOUND FROM 0 TO 10 CM PROXIMAL TO THE ANUS.