MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	304387
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle safetyglide 23x1-1/2 rb tw had a syringe needle connectivity issue.The following information was provided by the initial reporter: material # 304387 batch # unknown.It was reported by the customer that the safety needles have a flimsy actual needle and are hard to activate the safety on.Verbatim: rcc received a complaint via email.Email(s) attached i don't know if anyone has told you but*** is very concerned about our new "safety" needles.The actual needle is flimsy but it is hard to activate the safety on it.The nurses feel like they are going to stick themselves because their finger is trying to slide it up.What happens is their finger pushes to engage the safety piece and it slips off of it and goes to the top of the needle.It did actually happen in.Additional information provided: i think we figured out the issue.It was happening with non-lure lock syringes.1.When trying to activate the safety using the table top method it would fly off the syringe without engaging.2.If using the finger to slide it up it is hard to activate with "wet" gloved hands it is hard to activate and the finger would slide up the device without engaging.However, getting new devices for the non-lure lock syringes.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - syringe needle connectivity issue as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW
• 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: 22398640
• Report Number: 1213809-2025-00454
• Device Sequence Number: 8639276
• Product Code: FMI
• UDI-Device Identifier: 30382903043874
• UDI-Public: (01)30382903043874
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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: 304387
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown