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

Catalog Number	306616
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd safetyglide¿ needle the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: needles not allowing us to put the vaccine through.Customer reported: we have recently had some issues with needles not allowing us to put the vaccine through.It was happening occasionally, but i just watched a nurse go through four needles before she found one that would work the mfr# (b)(4) prevent sg 25gx1in needle lot 2188472 (b)(6) 2027.This is also happening with the same brand needles at my other practice.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-aug-2023.Investigation summary: five samples were provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.One sample expelled the solution with a normal flow.The other four samples did not expel the solution; these needles are clogged.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 while using bd safetyglide¿ needle the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: needles not allowing us to put the vaccine through customer reported: we have recently had some issues with needles not allowing us to put the vaccine through.It was happening occasionally, but i just watched a nurse go through four needles before she found one that would work the mfr# 192-n251s prevent sg 25gx1in needle lot 2188472 06-30-2027.This is also happening with the same brand needles at my other practice.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17385309
• Report Number: 1213809-2023-00749
• Device Sequence Number: 14998184
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: (01)10612479248578
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Foreign,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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 Catalogue Number: 306616
• Device Lot Number: 2188472
• 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: 06/30/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/24/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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