MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: lot #: potential no.: 220812c.D4: udi: (b)(4).H4: device manufacture date: 12 aug 2022.
Event or Problem Description
The user facility reported that a 35-year-old female received a sublocade injection on (b)(6) 2024, as reported by an addiction/infectious disease nurse manager.The patient returned to the office on (b)(6) 2024, with cellulitis at the injection site.Incision and drainage (i&d) were performed, and a wound culture identified pantoea agglomerans, a bacterium sometimes found in contaminated medical supplies.Additional information was received on 30 aug 2024: the nurse advised that no medical supplies were tested for contamination.

• Brand Name: TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna, phl ; RP
• MDR Report Key: 20328437
• Report Number: 2243441-2024-00030
• Device Sequence Number: 18050001
• Product Code: FMI
• UDI-Device Identifier: 34806017510719
• UDI-Public: (01)34806017510719(17)270731(10)220811C
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 09/27/2024
• Report Date (Section F): 09/27/2024

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: N/A
• Device Catalogue Number: SG3+1916
• Device Lot Number: 220811C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/29/2024
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2024
• 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: SUBLOCADE INJECTION.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/27/2024