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

Catalog Number	305917
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle sftygld 21x1-1/2 rb tw needle pulled out of the hub.The following information was provided by the initial reporter: we would like to inform you that we have been informed by our customer that the cannula came loose from the plastic part [luer lock] during administration.(see picture).Affected by this is: our item 46159502 fspr-bd safety glide needle 21x1 1/2" your item: 305917 our batch: 4302952 our purchase order: (b)(4).Delivered on: (b)(6) 2024.Your batch: 3324374.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub.One sample and one photo were provided to the quality team for investigation.Visual inspection revealed that the needle hub¿s safety mechanism was activated, with the needle protruding from the hub and approximately 60% of its outer diameter covered in epoxy.The photo confirmed the condition of the sample received.Based on the investigation and sample analysis, the symptom reported has been confirmed.The probable root cause may be a jam at the cannulator, which could have induced the reported condition and remained undetected during subsequent processing.Verification of the cannulator showed that the settings were correct and product flow was normal.Furthermore, a device history record (dhr) review was completed for the provided lot number 3324374.The review showed no rejected inspections or quality issues during production that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured in trend reports and monitored monthly.Our business team regularly reviews the collected data to identify any emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: 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: 22537903
• Report Number: 1213809-2025-00482
• Device Sequence Number: 7819299
• Product Code: FMI
• UDI-Device Identifier: 00382903059171
• UDI-Public: (01)00382903059171(11)231120(17)281031(10)3324374
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 305917
• Device Lot Number: 3324374
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown