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

Catalog Number	305901
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
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 25x5/8 rb needle pulled out of hub.Complaint via email.The needles seem to not be seated correctly and are breaking off when used to draw up injections.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that the needles may not be properly seated and that they are breaking off during use when drawing up injections.To support the investigation, the quality team received eight samples in unopened blister packaging and one photograph for evaluation.A visual inspection of the returned samples identified no defects or irregularities.The epoxy at the needle hub to needle junction was also found to be acceptable on all inspected units.The photograph provided depicts a needle hub with the safety mechanism assembled to a syringe; the needle is not present on the assembly and appears to be inserted into a vial.A device history record review was completed for material number 305901, lot 5351062.The review confirmed that all required visual inspections were performed and that no quality notifications were documented 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 records for the needle lots used in the manufacture of the finished lot were reviewed.No documentation of this defect was identified throughout the production run of the reviewed lots.To date, no other similar events have been reported for this lot.Based on the investigation, including review of the photographic evidence, the customer reported symptom is confirmed.However, without the failed physical sample available for analysis, a probable root cause could not be determined.

• 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: 24956486
• Report Number: 1213809-2026-00215
• Device Sequence Number: 17462909
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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: 5351062
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2025
• 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