MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305903
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 ml bd safetyglide¿ insulin syringe with attached needle experienced leakage, and a needle that was pulled out of the hub.The following information was provided by the initial reporter: when attaching needle to syringe, there isn't a luer lock to hold the needle in place on syringe during administration.An injection to a patient in pediatrics, the needle stayed in the patient when withdrawing the syringe.No impact to patient.Syringe also leaks since there isn't a luer lock present and patients may not be receiving full doses.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Common device name: an additional common device name of piston syringe also applies to this device.Medical device type: an additional medical device type of fmf also applies to this device.Pma/510(k): an additional pma/510(k) of k980580 also applies to this device a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Common device name: an additional common device name of piston syringe also applies to this device.Medical device type: an additional medical device type of fmf also applies to this device.Pma/510(k): an additional pma/510(k) of k980580 also applies to this device a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 1 ml bd safetyglide¿ insulin syringe with attached needle experienced leakage, and a needle that was pulled out of the hub.The following information was provided by the initial reporter: when attaching needle to syringe, there isn't a luer lock to hold the needle in place on syringe during administration.An injection to a patient in pediatrics, the needle stayed in the patient when withdrawing the syringe.No impact to patient.Syringe also leaks since there isn't a luer lock present and patients may not be receiving full doses.
Event or Problem Description
It was reported that 1 ml bd safetyglide¿ insulin syringe with attached needle experienced leakage, and a needle that was pulled out of the hub.The following information was provided by the initial reporter: when attaching needle to syringe, there isn't a luer lock to hold the needle in place on syringe during administration.An injection to a patient in pediatrics, the needle stayed in the patient when withdrawing the syringe.No impact to patient.Syringe also leaks since there isn't a luer lock present and patients may not be receiving full doses.
Additional Manufacturer Narrative
Investigation summary: catalog p/n 305903 is marketed and sold as an "injection needle with luer slip syringe" per the unit product packaging.Note that the product instructions for use state to "push firmly when attaching the needle to the syringe", this will help ensure an adequate connection to the slip tip syringe.There are a few fundamental differences between luer-lock and luer-slip syringes.The luer-lock syringes require the tabbed hubs of the needle to screw into the threads normally present within the collar.The luer-slip syringe while maintaining the same luer tip taper as the luer-lock is designed to not include the collar and locking threads.The needle and syringe are instead pressed together and held together by friction.Since the reported condition is not a true defect and a design-related inquiry a potential root cause could not be established, dhr review is not applicable, and corrective actions are not necessary.H3 other text : see h10.

• Brand Name: 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13006745
• Report Number: 1213809-2021-00817
• Device Sequence Number: 19306330
• Product Code: FMI
• UDI-Device Identifier: 30382903059035
• UDI-Public: 30382903059035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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 Expiration Date: 01/31/2026
• Device Model Number: 305903
• Device Catalogue Number: 305903
• Device Lot Number: 1041340
• 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: 11/18/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown