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

Model Number	192-N251S
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2188470, d.4.Medical device expiration date: 30-jun-2027, h.4.Device manufacture date: 07-jul-2022, d.4.Medical device lot #: 2153548, d.4.Medical device expiration date: 31-may-2027, h.4.Device manufacture date: 02-jun-2022, d.4.Medical device lot #: 2188472, d.4.Medical device expiration date: 30-jun-2027, h.4.Device manufacture date: 07-jul-20222.H3.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 3 of the bd safetyglide¿ needle experienced leakage.The following information was provided by the initial reporter: leaks at the hub.
Additional Manufacturer Narrative
Investigation summary: no samples or photos received by our quality team for evaluation.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.During review of the process, process variations during the needle lubricant application can create clogged needles.Corrective and preventative actions have been implemented.Several quality initiatives have been implemented on our manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.
Event or Problem Description
It was reported that 3 of the bd safetyglide¿ needle experienced leakage.The following information was provided by the initial reporter: leaks at the hub.

• Brand Name: BD SAFETYGLIDE¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17333369
• Report Number: 1213809-2023-00734
• Device Sequence Number: 17794059
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: 10612479248578
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 07/21/2023

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: 192-N251S
• Device Catalogue Number: 306616
• Device Lot Number: 2188472
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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