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	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.4.: the initial reporter also notified the fda on 29jun2023.Medwatch report # mw5119122.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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: team member attempted to administer prevnar 13 vaccine.Prior to administration the team member was unable to pushed medication and eject air bubble from syringe.Needle discarded and new needle applied, vaccine was then successfully administered.No harm to patient as this was discovered prior to administration.
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: team member attempted to administer prevnar 13 vaccine.Prior to administration the team member was unable to pushed medication and eject air bubble from syringe.Needle discarded and new needle applied, vaccine was then successfully administered.No harm to patient as this was discovered prior to administration.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples or photos received by our quality team for evaluation.Furthermore, a device history record review was completed for provided batch number 2188470.According to the sampling plan applied for product performance, this batch was accepted and released without defects being noted during the final assembly or visual inspections.Additional device histories were reviewed for each lot of needles used in the manufacturing of this batch.During the history review, one lot was identified as having suffered from clogged needles due to silicone.It could be possible some samples are escapes from the incident that occurred during production.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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• 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: 17444877
• Report Number: 1213809-2023-00801
• Device Sequence Number: 11425001
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2023

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: 2188470
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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