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

Catalog Number	305902
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
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 23x1 rb needle pulled out of hub.Verbatim: rcc received a complaint via email.Email(s) attached.Needle embedded into cap and pulled out of hub when cap removed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported that the needle was embedded in the cap and was pulled out of the hub when the cap was removed.To support the investigation, one sample contained in an opened blister package was provided to the quality team for evaluation.A visual inspection was performed and confirmed that the needle was loose from the needle hub, with epoxy covering approximately 30 percent of the needles outer diameter.No additional defects or imperfections were observed.This condition could occur if a jam were to take place at the cannulator during manufacturing.A device history record review was completed for material number 305902, lot 4327907.The review confirmed that all required visual inspections were performed in accordance with established requirements, and no quality notifications related to the reported condition were identified.The lot was inspected and accepted per the inspection control plan and subsequently approved for shipment.Additional device history records were reviewed for each lot of needles used in the manufacture of this final lot, and no documentation of this type of defect was identified throughout the production runs.Verification of the cannulator was performed.The settings were correct and flow of product was satisfactory.To date, no other similar events have been reported for this lot.Based on the results of 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: 24317063
• Report Number: 1213809-2026-00057
• Device Sequence Number: 17362325
• Product Code: FMI
• UDI-Device Identifier: 00382903059027
• UDI-Public: (01)00382903059027(11)241122(17)291031(10)4327907
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 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: Other
• Device Catalogue Number: 305902
• Device Lot Number: 4327907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• 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: 11/22/2024
• 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: Unknown