MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1/2 RB; 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	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported endophthalmitis.Event description: material # 305106.Batch # 4060059, 4031552.My name is (b)(6), i'm a retinal technician, and i'm sending this message on behalf of (b)(6) and in regard to the 30g x 1/2 (0.3mm x 13mm) needles (ref - 305106).Over the past month we've seen an increase in our endopthalmitis rate (this has been irrespective of clinician or drug being given).Since this wave of infections, we have changed all the variables on our end that were able to (i.E.The manner in which we numb patients, discarding numbing drops, etc).The only common denominator amongst all of these instances is the brand of and lot #s of the needles that has been used (lots 4060059 and 4031552).We've been monitoring the website as well the bd website of all recalls and we haven't seen any recent recalls with these specific lot's (4060059 and 4031552).We're inquiring to see if there may have been other clinics reporting an increase in their endophthalmitis rate and associated with the use of these specific lot #'s of 30g needles.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

• Brand Name: NEEDLE 30X1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22823812
• Report Number: 1911916-2025-00586
• Device Sequence Number: 18337062
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290331(10)4031552
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 305106
• Device Lot Number: 4031552
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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