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

Catalog Number	305918
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
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 18x1-1/2 rb contained foreign matter.Verbatim: rcc received a complaint via email.Email(s) attached.I just received a notification from one of our nurse managers at chester facility.Her staff have reported to her they are noticing particles of plastic when using this needle.Upon noticing this, they have now moved to using a different needle and are not seeing the particles with the different needle.We have pulled the needles from use with this specific lot number until further notice.We have been notified of an issue with the 18g x 1 inch needle (mpn 305918) specific lot number 5321940.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: the customer reported observing plastic particles during use of this needle.To support the investigation, five samples and three photographs were received for evaluation by the quality team.Three samples arrived without blister packaging and two arrived in sealed blister packs.A visual inspection was performed, no foreign matter was observed at the needle hub, needle, or plastic shield.The photographs depict a needle assembled to a syringe containing a white solution, with a dark speck visible at the bottom of the syringe.Based on the images, it is not possible to determine whether the speck is embedded, and no additional information could be obtained from the photographs.A device history record review was completed for material number 305918, lot 5321940.All required visual inspections were performed in accordance with specifications, with no quality notifications related to the reported condition.The lot was inspected and accepted per the inspection control plan and released for shipment.Device histories for the needle component lots used in the manufacture of this final lot were also reviewed, no documentation of this defect type was identified during the production runs.To date, no other similar events have been reported for this lot.Based on the investigation, including analysis of the returned samples, the reported condition could not be 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: 24405194
• Report Number: 1213809-2026-00085
• Device Sequence Number: 9748386
• Product Code: FMI
• UDI-Device Identifier: 00382903059188
• UDI-Public: (01)00382903059188(11)251117(17)301031(10)5321940
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 305918
• Device Lot Number: 5321940
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2025
• 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