MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 23X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle sftygld 23x1 rb safety mechanism was difficult to activate.The following information was provided by the initial reporter: material#: 305902, batch#: 3352622.It was reported by customer that 2 different nurses were stuck by needles when trying to cover the needle.The needle bent and stuck both people.Verbatim: rcc received a complaint via email.Email(s) attached item(s): 305902.Lot(s): 3352622.Date incident occurred:last month and then today (b)(6) 2025.Was the patient impacted? if yes, describe: 2 different nurses were stuck by needles when trying to cover the needle.The needle bent and stuck both people.Is a sample available?: no.Customer request?: please call.Concerned with faulty design.Additional information provided: the correct lot # is 3352622.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(6) - supplemental mdr.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SFTYGLD 23X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21708958
• Report Number: 1213809-2025-00224
• Device Sequence Number: 21334834
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028(11)231218(17)281130(10)3352622
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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,Followup
• Report Date (Section B): 04/21/2025

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: 305902
• Device Lot Number: 3352622
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown