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

Catalog Number	305916
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
Event or Problem Description
It was reported that bd needle sftygld 25x1 rb needle pulled out of hub.Rcc received a complaint via email.During administration of vaccines, on two separate occasions, the 25g 1" needle became loose from the hub and remained in the pediatric patient's skin following the injection.The needle was removed by the team member.No patient harm noted for either patient.This report involves two separates pediatric patients with 2 different lot numbers of the same gauge and length bd safetyglide needle.Lot numbers involved patient #1 (b)(6) 2026 lot 5197895 exp 6/30/2030.Patient #2 (b)(6) 2026 lot 5174468 exp 5/31/2030.Health effect code: 4582.Device problem code: 1371, 3015.
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)(4) follow up for device evaluation.Two samples were received in sealed blister packaging and underwent visual inspection.No defects or imperfections were observed, and the epoxy was confirmed to fully cover the needle to hub joint.Based on the investigation and evaluation of the samples, the reported condition could not be confirmed.As no actual defect was identified during the analysis, a probable root cause could not be determined.Furthermore, a device history record review was completed for provided lot number 5197895.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.

• 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: 24640654
• Report Number: 1213809-2026-00138
• Device Sequence Number: 18684219
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(11)250623(17)300531(10)5174468
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 305916
• Device Lot Number: 5197895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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: Unknown