MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 23X1-1/2 RB TW; Needle, Hypodermic, Single Lumen

Catalog Number	305194
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ecchymosis (1818); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, needle 23x1-1/2 rb tw, leaking occurred as a result of difficulty with getting the cap off.The following was provided by the initial reporter: patient reports "i was having difficulty removing the needle cap from the mixing needle and some of the fluid pushed out so there wasn't enough diluent in the gattex vial.I think i hit a vein when i gave my injection once because there is a bruise that is still present.I have high anxiety, so i have to take some deep breaths." (b)(6)2026 ms spoke with pt on phone.Sample discarded and pt used another syringe.No pictures available.Pt did not miss dose.Pt confirmed that the leaking occurred as a result of difficulty with getting the cap off.Ae: bruising at injection site.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

• Brand Name: NEEDLE 23X1-1/2 RB TW
• 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 ; +1(847)393-5694
• MDR Report Key: 50483960
• Report Number: 1911916-2026-00448
• Device Sequence Number: 10173166
• Product Code: FMI
• UDI-Device Identifier: 00382903051946
• UDI-Public: (01)00382903051946(11)240926(17)291130(10)4270072
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305194
• Device Lot Number: 4270072
• 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: 08/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown