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	Insufficient Information (4580)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown 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: it was not the syringe that was giving us issues, it was the needle not allowing us to inject the vaccine into the patients.The syringe was allowing us to draw up the vaccine however when we tried to inject the vaccine the needle would not allow the solution to go through the needle.However, we did have a couple of incidents where a patient had to get poked twice due to us having to swap out the needles.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received by our quality team for evaluation.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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: it was not the syringe that was giving us issues, it was the needle not allowing us to inject the vaccine into the patients.The syringe was allowing us to draw up the vaccine however when we tried to inject the vaccine the needle would not allow the solution to go through the needle.However, we did have a couple of incidents where a patient had to get poked twice due to us having to swap out the needles.

• 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: 17421406
• Report Number: 1213809-2023-00783
• Device Sequence Number: 20578692
• Product Code: FMI
• UDI-Device Identifier: 10612479248578
• UDI-Public: (01)10612479248578
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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
• 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: UNKNOWN
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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