MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305930
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
Type of Reportable Event	Malfunction
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
It was reported that the bd syringe safety glide 1ml w/ndl 27x3/8 ib safety mechanism was broken.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Facility contact: xxxxxx department: materials management xxxxxx product catalog number: 303327.Product description: needle syringe 0.375in 1ml bd general-purpose sterile disposable safety glide /ndl 27x3/8 ib origin of the issue: nursing detail: lot #: employee health alerted supply chain that employee "reported having several near misses with this item because the safety didn't engage properly and pushed the needle away instead of covering it" number of occurrences: 2.0 sample available: no.Lot number: 5160270l1.Additional information provided: any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Employee stuck herself with the needle while trying to recap.She reported past near-misses from the same system previously where the cap did not cover the tip of the needle, but we don't have previous reports with lot number incriminated.Can you please provide an exact date of event in format dd-mmm-yyyy? 14/12/2025 please confirm the lot number, given lot # 5160270l1 is not valid for mat # 303327.Ref number is 305930 lot number is correct, see picture 5160270l1.
Event or Problem Description
Codes.
Additional Manufacturer Narrative
No photo or sample was received for the customer's complaint of safety mechanism failures.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Codes.
Additional Manufacturer Narrative
No photo or sample was received for the customer's complaint of safety mechanism failures.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.The manufacturer has been notified of this occurrence.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23997407
• Report Number: 2243072-2025-01563
• Device Sequence Number: 10523830
• Product Code: FMI
• UDI-Device Identifier: 00382903033270
• UDI-Public: (01)00382903033270
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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,Followup
• Report Date (Section B): 01/29/2026

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: 305930
• Device Lot Number: 5160270L1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 01/29/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/27/2026; 02/05/2026
• 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