MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY, 18 G X 1 1/2 IN.; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305918
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported while using bd safetyglide¿ needle only, 18 g x 1 1/2 in.Leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking at fused connection while mixing medication.No effect - did not reach patient - detected before use or does not touch person during use.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-mar-2023.Investigation summary one sample was provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution.It showed a leak of solution at the needle joint.A pin hole was observed where the epoxy holding the needle to the needle hub.This defect could occur during manufacturing if a jam occurred at the cannulator inducing the symptom reported and not detected in the next processes.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported while using bd safetyglide¿ needle only, 18 g x 1 1/2 in.Leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking at fused connection while mixing medication.No effect - did not reach patient - detected before use or does not touch person during use.
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
Event or Problem Description
It was reported while using bd safetyglide¿ needle only, 18 g x 1 1/2 in.Leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: leaking at fused connection while mixing medication.No effect - did not reach patient - detected before use or does not touch person during use.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE ONLY, 18 G X 1 1/2 IN.
• 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 ; 8448235433
• MDR Report Key: 16427788
• Report Number: 1213809-2023-00111
• Device Sequence Number: 14763982
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: (01)30382903059189
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2023

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: 305918
• Device Catalogue Number: 305918
• Device Lot Number: UNKNOWN
• 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: 01/27/2023
• Supplement Date Received by Manufacturer: 02/27/2023; 03/17/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/09/2023; 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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