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

Catalog Number	305917
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 sftygld 21x1-1/2 rb tw had foreign matter.The following information was provided by the initial reporter: it was reported that we would like to inform you that we have been informed by our customer that there are ochre-coloured ¿crumbs¿ in the green area shown.(see picture).
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation one sample was received in an opened blister package and visually inspected.The needle hub contained embedded brown specks, and no other defects were observed.A photo was provided showing the received sample.The probable root cause is related to the molding process, where degraded resin can occur during injection mold start-up or intermittently during production.This material builds up in the mold and press system and may break loose, becoming embedded in molded components.Additionally, a device history record review was completed for lot number 4108498, which showed no rejected inspections or quality issues during 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: 23647352
• Report Number: 1213809-2025-00740
• Device Sequence Number: 4824807
• Product Code: FMI
• UDI-Device Identifier: 00382903059171
• UDI-Public: (01)00382903059171(11)240417(17)290331(10)4108498
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: Other
• Device Catalogue Number: 305917
• Device Lot Number: 4108498
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown