MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SYRINGE WITH NEEDLE; SYRINGE, PISTON

Model Number	SS-10L2125
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Rash (2033); Numbness (2415); Skin Burning Sensation (4540); Swelling/ Edema (4577)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported a patient scheduled for iud replacement in 2 weeks.During the preparation of the last vial of remicade, the vial exploded, causing the medication to spill onto the nurse's face, neck, and chest.Upon closer inspection, a crack was found in the syringe, which led to the leakage.Despite this, the patient received the full dose as only a portion of the vial was needed.The nurse experienced a swollen and numb face, burning lips, and a rash on her face and chest.Oral benadryl was taken to address these symptoms.Additional information received on 12 nov 2024: the nurse is now stable and has seen their family doctor, who prescribed prednisone and blexten.The actual patient was not impacted in any way.

• Brand Name: TERUMO SYRINGE WITH NEEDLE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; no. 124 east main ave; laguna technopark; binan, laguna 4024 ; RP 4024
• MDR Report Key: 20873088
• Report Number: 2243441-2024-00043
• Device Sequence Number: 8831765
• Product Code: FMF
• UDI-Device Identifier: 34806017511358
• UDI-Public: 34806017511358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024
• Report Date (Section F): 12/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SS-10L2125
• Device Lot Number: 230515L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2024
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REMICADE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 12/06/2024