MAUDE Adverse Event Report: TERUMO EUROPE N.V TERUMO; OPHTHALMIC NEEDLE

Model Number	NF-3013RBKE05M
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
Health Effect - Clinical Codes	Endophthalmitis (1835); Intraocular Infection (1933)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the complaint involves filter needles co-packed with vabysmo.A patient developed a bacterial eye infection five days after receiving the medication.The infection required surgical treatment at an ophthalmology clinic.The reporting clinic indicated that the infection may have been associated with the medication.The case was forwarded from the drug commission of the german medical association (amk) to the regional council tübingen (rp tübingen).The infection occurred following the most recent injection; the previous nine injections were well tolerated, including two pre-filled syringes.The first injection in (b)(6) 2024 and one of the pre-filled syringes were from different batches.The patient was hospitalized for one week following surgical treatment.The patient was being treated for wet macular degeneration.The event occurred post-treatment.Surgical intervention was required.The final patient impact was partial recovery; improvement was noted, but full recovery had not yet occurred.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age or date of birth: born year 1942.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: device quality manager.A batch record review was conducted for lot 2409001 (nf3013rbke05m).During needle assembly, 315 needles were visually inspected per shift for foreign matter.One nonconformity related to foreign matter was identified.Corrective actions were implemented, including visual inspection of the products and additional cleaning of the machine.This nonconformity is not considered relevant to the reported complaint.During packaging, 40 needles were visually inspected twice per shift for foreign matter.No abnormalities related to the complaint were reported.A final visual inspection was performed on 1,500 pieces, with no abnormalities observed.As part of the final inspection, particulate matter testing was conducted on 84 pieces and visual inspection on 13 pieces.All results conformed to specifications.The limulus amebocyte lysate (lal) test and sterilization cycle were executed according to specifications, with no observations reported.The sample associated with the complaint was not returned for evaluation.Retention samples were visually inspected for foreign matter on august 8, 2025, with no defects identified.Based on the batch record review and retention sample inspection, no root cause related to the production process was identified.No causal relationship could be established.Trend and deviation reviews revealed no similar actions.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo europe n.V.(manufacturer) registration no.(b)(4).

• Brand Name: TERUMO
• Common Device Name: OPHTHALMIC NEEDLE
• Manufacturer (Section D): TERUMO EUROPE N.V; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• Manufacturer (Section G): TERUMO EUROPE N.V.; interleuvenlaan 40; leuven, vlaams brabant 3001 ; BE 3001
• Manufacturer Contact: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22801212
• Report Number: 9681413-2025-00004
• Device Sequence Number: 21098202
• Product Code: QYM
• UDI-Device Identifier: 05413206251223
• UDI-Public: 05413206251223
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K230951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: NF-3013RBKE05M
• Device Catalogue Number: NF-3013RBKE05M
• Device Lot Number: 2409001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SYRINGE (FOR PRODUCT VABYSMO)
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Male