MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	10/17/2025
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 # 305106 batch # 3347539.It was reported by customer that patient developed post-injection endophthalmitis following intravitreal injection using bd precisionglide needle.Rcc received a complaint via email.Post-procedure infection: endophthalmitis.Patient with known central retinal vein occlusion (crvo) and macular edema on chronic intravitreal eylea injection therapy developed post-injection.Endophthalmitis in the right eye.Patient received usual intravitreal injection of eylea 2mg od on (b)(6) 2025.Injection procedure was without complication.The following day developed pain and decreased.Vision prompting a visit to the mercy ed.On examination she was noted to have significant intraocular.Inflammation and markedly reduced vision concerning for acute endophthalmitis.She was taken.Urgently to the operating room on (b)(6) for vitrectomy/vitreous biopsy (bx) + intravitreal injection.Of abx(antibiotics).Cultures grew streptococcus mitis group.Endophthalmitis represents a rare but serious complication of intravitreal injection with potential for significant visual morbidity.Model #: 305106 lot #: 3347539.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported there was post-injection endophthalmitis following intravitreal injection using a bd precisionglide needle.Our quality team has completed a device history record review for material number 305106 and lot number 3347539.The review did not identify any abnormalities during the production process that could have contributed to the defect, and all quality tests were within specification.Due to the unavailability of a sample for return, a comprehensive sample investigation could not be conducted.Consequently, the exact cause of this incident remains undetermined.Should you encounter any further issues with our product, we would appreciate the opportunity to perform a detailed analysis.At this time, no further action is deemed necessary.

• Brand Name: BD PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 23772196
• Report Number: 1911916-2025-00785
• Device Sequence Number: 13192421
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290228(10)3347539
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 305106
• Device Lot Number: 3347539
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2023
• 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