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

Catalog Number	305916
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2026
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 25x1 rb contained foreign matter.Verbatim: possible mold inside individual product packaging.
Additional Manufacturer Narrative
(b)(4).Follow up a customer reported possible mold within an individual product package.Because no physical sample was returned, a comprehensive evaluation could not be performed.To support the investigation, the quality team reviewed three photographs of a 25 x 1 inch safetyglide needle package.The photographs, taken from different angles, show a single sealed package containing an unidentified black spot located inside the package and outside the fluid path.The spot cannot be categorized from the photos received.The condition observed is a nonconformance to product specifications and is considered associated with the packaging process.A device history record review was completed for material number 305916, lot 5293541.The review confirmed that all required visual inspections were performed in accordance with applicable requirements, and no quality notifications were identified related to the reported condition.The lot was inspected and accepted per the established inspection control plan, released for shipment, and considered compliant with product specification requirements at the time of release.To date, no additional similar events have been reported for this lot.Based on the information available, the presence of an unidentified black spot within the sealed package, as depicted in the photographs, 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: 24583559
• Report Number: 1213809-2026-00112
• Device Sequence Number: 13350984
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(11)251020(17)300930(10)5293541
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2026

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: 305916
• Device Lot Number: 5293541
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2025
• 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