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

Catalog Number	305901
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle sftygld 25x5/8 rb contained foreign matter.Complaint via phone.Case description: there is a hair sticking out of the cap, she can even see the hair follicle.Product: bd safetyglide¿ needle 25 g x 5/8 in.Ref#: 305901, lot#: 5080421.Can you please provide an exact date of event in format dd-mmm-yyyy? 19-mar-2026.Any sample or photo available for investigation? describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Near miss.No patient harm occurred.Nurse went to attach the needle to syringe but could clearly see the hair sticking out of the cap and did not use the product.
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 it was reported that a hair was protruding from the cap.To support the investigation, the quality team received one sample with an opened blister package and two photographs for evaluation.A visual inspection confirmed a hair trapped between the needle hub and the plastic shield.The photographs provided correspond to the sample received.No additional defects or abnormalities were observed.This condition could result from a gowning nonconformance.A device history record review was completed for material number 305901, lot 5080421.The review confirmed that all required visual inspections were performed and that no quality notifications were generated related to the reported condition.The lot was inspected and accepted in accordance with the inspection control plan and was approved for shipment.In addition, device history documentation was reviewed for each lot of needles used in the manufacture of the final lot, and no records of this defect type were identified throughout the production run.The sample will be used for associate awareness.Based on the investigation and returned sample evaluation, the customer reported condition 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: 24791164
• Report Number: 1213809-2026-00176
• Device Sequence Number: 13222839
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010(10)5080421
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• 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: Health Professional
• Device Catalogue Number: 305901
• Device Lot Number: 5080421
• 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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• 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