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

Catalog Number	305918
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
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 the bd needle sftygld 18x1-1/2 rb had foreign matter.The following information was provided by the initial reporter: material # 305918 batch # 5099521.Reporting a safety needle that looks to be contaminated with what appears to be plastic shavings on the needle.Customer response on (b)(6) 2025.Exact date of occurrence was (b)(6) 2025.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation a single sample was received in opened blister packaging and subjected to visual inspection, which revealed visible lubricant spots on the needle.The reported symptom was confirmed through sample analysis.The probable root cause is attributed to a potential jam during the lubricant application process, which may have gone undetected in subsequent manufacturing stages.Furthermore, a device history record (dhr) review was completed for the provided lot number 5099521.The review 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: 22967595
• Report Number: 1213809-2025-00577
• Device Sequence Number: 9142294
• Product Code: FMI
• UDI-Device Identifier: 00382903059188
• UDI-Public: (01)00382903059188(11)250409(17)300331(10)5099521
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/19/2025

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: Health Professional
• Device Catalogue Number: 305918
• Device Lot Number: 5099521
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown