MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NOT APPLICABLE; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
The following information was provided by the initial reporter: material # 305200.Batch # 2172517.Verbatim: adverse event - endophthalmitis patient experienced an adverse event post injection.
Additional Manufacturer Narrative
(b)(4).Follow up report for additional information provided by customer on 07-jan-2026: ¿on (b)(6) 2025 at 7:19 am drop was diluted using britm technique with proparacaine 0.5% drops, tropicamide 1% and phenylephrine 2.5% in os.¿ "prescription was sent to pharmacy for durezol 0.5mg every hour alternates with olfloxacin 0.3mg every hour.¿.
Event or Problem Description
Additional information provided by customer on 07-jan-2026: what medical intervention was provided to patient? ¿on (b)(6) 2025 at 7:19 am drop was diluted using britm technique with proparacaine 0.5% drops, tropicamide 1% and phenylephrine 2.5% in os.¿ "prescription was sent to pharmacy for durezol 0.5mg every hour alternates with olfloxacin 0.3mg every hour.¿.
Additional Manufacturer Narrative
Additional information: (b) date of event has since been clarified.Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information.

• Brand Name: NOT APPLICABLE
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23937410
• Report Number: 1911916-2025-00818
• Device Sequence Number: 21214334
• Product Code: GAA
• UDI-Device Identifier: 00382903052004
• UDI-Public: (01)00382903052004(17)270630(10)2172517
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 305200
• Device Lot Number: 2172517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/14/2026; Not provided
• Initial Report FDA Received Date: 12/31/2025
• Supplement Report FDA Received Date: 01/14/2026; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown