MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305901
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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 bd needle sftygld 25x5/8 rb needle pulled out of hub.Verbatim: rcc received a complaint via email.Email(s) attached.25g 5/8 in.Needle came apart from the hub when giving an injection to infant.Medication administered and when removing from the thigh the needle separated from the hub and remained in place.It did not stay intact with the syringe and safety cover.Staff was able to remove needle from thigh, with no retained equipment.Used with bd 1 ml syringe with leur-lok tip, lot # 5260229 and expiration date of 8-31-2030.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported that the needle separated from the hub.To support the investigation, one sample without a packaging blister or plastic shield was received and evaluated by the quality team.A visual inspection confirmed that the needle was loose and detached from the hub.Approximately 40 percent epoxy coverage was observed on the outer diameter of the needle.No additional defects or abnormalities were identified.This condition could potentially occur if a jam were present at the cannulator during processing.A review of the device history record was conducted for material number 305901, lot 5314139.The review confirmed that all required visual inspections were completed in accordance with established procedures, with no quality notifications related to the reported condition.The lot met acceptance criteria per the inspection control plan and was approved for shipment.Device history records for each needle lot used in the manufacture of this final lot were also reviewed, and no documentation of this type of defect was identified throughout the entire production run.Verification of the cannulator was performed, confirming that equipment settings were within specification and product flow was satisfactory.To date, no additional similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the condition reported by the customer is confirmed.

• Brand Name: BD SAFETYGLIDE
• 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: 24318286
• Report Number: 1213809-2026-00060
• Device Sequence Number: 20049180
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(11)251110(17)301031(10)5314139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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: 305901
• Device Lot Number: 5314139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Hispanic