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

Catalog Number	306616
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 306616 batch # 5010901 it was reported that the bd safetyglide needle pulled out of the hub.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached complaint number (b)(4).Report date - 03.11.25 mfr reorder # (b)(4).Product name - needle, sfty 192-n251s prevents org 25gx1" lot / serial number - (b)(6).Product concern - needle detached/came off hub while in the patient's arm.
Additional Manufacturer Narrative
(b)(4).Follow up report for correction.Date of event should be 03/10/2025.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(6) - supplemental mdr - needle pulled out of hub.Three hundred samples were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.Epoxy on the needle/needle hub looked correct.Twenty samples were randomly selected for cannula pull test and obtained result is well within specification.Additionally, two photos and one video were provided to our quality team for investigation.The photo shows a needle assembly assembled to a syringe and the safety mechanism has been activated.The top part of the needle is in the safety mechanism and the bottom part of the needle is out of the needle hub.Furthermore, a device history record review was completed for provided lot number 5010901.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• 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: 21718702
• Report Number: 1213809-2025-00225
• Device Sequence Number: 19815590
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598(11)250110(17)291231(10)5010901
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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,Followup
• Report Date (Section B): 04/14/2025

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: 306616
• Device Lot Number: 5010901
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: Not provided; 04/14/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 03/28/2025; 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown