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	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that the needle became dislodged from the base.To support the investigation, one sample in an opened blister package and two photographs were provided to the quality team for evaluation.A visual inspection of the returned sample confirmed that the needle had separated from the needle hub.Epoxy coverage was insufficient, covering approximately 40 percent of the hubs outer diameter.The photographs depict a needle assembled to a syringe, in both images, the needle appears to be out of the needle hub and retained by the safety mechanism.No additional defects or irregularities were observed.This condition may be attributable to a jam at the cannulator.A device history record review was completed for material number 305901, lot 5353719.The review confirmed that all required visual inspections were performed and that no quality notifications were identified related to the reported condition.The lot was inspected and accepted in accordance with the inspection control plan and subsequently approved for shipment.In addition, device histories for each needle lot used in the manufacture of the final lot were reviewed, no instances of this defect were documented throughout the production runs for these lots.Cannulator verification was also performed, and the settings were confirmed to be correct with acceptable product flow.To date, no other similar events have been reported for this lot.Based on the investigation results and returned sample evaluation, the condition reported by the customer is confirmed.
Event or Problem Description
It was reported that bd needle sftygld 25x5/8 rb needle pulled out of hub.Complaint via email.We have received a quality complaint on product sold to our customer.Please contact the customer, (b)(6), and include complaint#: (b)(4) on any future communications.Injuries or adverse event: no.Item: 305901.Quantity affected:1 each.Serial/lot number: (b)(6).Po: (b)(4).Are any samples available for return? yes.Reported issue: the needle out of the patient's injection site and engaged the safety, the needle came dislodged from the base on the needle.Customer disposition request: credit.Customer contact information: (b)(6).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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: 24905933
• Report Number: 1213809-2026-00201
• Device Sequence Number: 9827963
• Product Code: FMI
• UDI-Device Identifier: 00382903059010
• UDI-Public: (01)00382903059010
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 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: Other
• Device Catalogue Number: 305901
• Device Lot Number: 5353719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 04/16/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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