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

Model Number	306609
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd safetyglide¿ needle only the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: customer reported team member administered vaccine subcutaneously in right thigh.Administration of vaccine was complicated by the need for additional force on the plunger required to inject medication-team member reports that the needle felt blocked.Full dose of medication was administered over longer than usual time.No harm to patient- no extra injection required.
Additional Manufacturer Narrative
E.4.: the initial reporter also notified the fda on 19may2023 medwatch report # mw5118115 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
H6: investigation summary eleven samples were randomly selected 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.All the samples expelled the solution with normal flow, clogged needle was not confirmed.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.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 only the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: customer reported team member administered vaccine subcutaneously in right thigh.Administration of vaccine was complicated by the need for additional force on the plunger required to inject medication-team member reports that the needle felt blocked.Full dose of medication was administered over longer than usual time.No harm to patient- no extra injection required.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE ONLY
• 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: 17276165
• Report Number: 1213809-2023-00694
• Device Sequence Number: 12055328
• Product Code: FMI
• UDI-Device Identifier: 10612479262567
• UDI-Public: 10612479262567
• 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): 07/19/2023

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: 306609
• Device Catalogue Number: 306609
• Device Lot Number: 2258318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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