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

Catalog Number	305916
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle sftygld 25x1 rb needle pulled out of hub.Verbatim: complaint via email.Email(s) attached report incident or problem information.Reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2026.Site name/location: level of harm: temporary harm.Alberta optional report to cmdsnet (health canada): yes.Incident details: patient required haldol intramuscular injection, upon administration to l thigh and removal of needle- needle remained in thigh and separated from plastic piece.Patient thrashing around, advised patient to relax, writer was able to remove needle manually.Who was affected? patient procedure: bd safety glide needle 25 g x 1 - intramuscular injection device information device name/description: needle hypodermic safety 25ga x 1 in manufacturer: manufacturer code/model: 305916.Serial or lot number: (b)(6) device expiry date (yyyy-mm-dd): 2027-09-30.Supplier: supplier catalogue number: (b)(4).Was the device retained? no.Investigation request.Expected type of investigation: lot review.Clinical contact information.Manager (cc on final report): filing reference id: (b)(4).End of report.Yes, the metal needle separated from the plastic hub.
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: 25046956
• Report Number: 1213809-2026-00227
• Device Sequence Number: 9643185
• Product Code: FMI
• UDI-Device Identifier: 00382903059164
• UDI-Public: (01)00382903059164(11)221014(17)270930(10)2287687
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 305916
• Device Lot Number: 2287687
• 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: 04/10/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2022
• 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