MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD Safety-Lok; Needle, hypodermic, single lumen

Model Number	305902
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Two needles from the same lot number bent when trying to inject medication to a patient struggling against restraint.Needle bent on contact with patient skin, not when needle was in the patient's body.The first needle bent on "[redacted]" when trying to inject the patient and the second needle bent on "[redacted]"-the next day when trying to inject the same patient.The first needle bent at a 90- degree angle and the second needle bent in a curved fashion.Proper intramuscular injection technique was maintained (injecting at a 90-degree angle, securing and isolating the muscle, physical hold applied correctly).Both times required a second physical hold and delayed treatment of the patient as a second needle needed to be obtained for medication administration.

• Brand Name: BD Safety-Lok
• Common Device Name: Needle, hypodermic, single lumen
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 50713853
• Report Number: 50713853
• Device Sequence Number: 10585961
• Product Code: FMI
• UDI-Device Identifier: 00382903059027
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/23/2026
• Report Date (Section F): 06/23/2026

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 Model Number: 305902
• Device Catalogue Number: 305902
• Device Lot Number: 3312252
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/23/2026