MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	306609
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 only, 25 g the needle fell out of the hub.There was no report of patient impact.The following information was provided by the initial reporter: while pulling out of patient's arm, needle fell off of base.
Additional Manufacturer Narrative
Two photos of a 25x5/8" safetyglide needle were received by bd.A quality engineer was able to review the photos from lot #2006959 regarding item #306609.One image shows the package with all applicable product information visible on the top web.The next image shows the loose safetyglide needle with the cannula separated from the needle hub.The condition observed is non-conforming per product specification.Potential root cause for needle pulled out of hub defect is associated with the needle supplier¿s manufacturing process.These conditions are occurring at/below their expected frequency.Therefore, no corrective actions are required for needle packaging site at this time.The samples will be forwarded to the needle supplier for further evaluation and investigation.Supplier investigation: based on the investigation and with the photo sample analysis, the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.A device history record review was completed for provided batch number 2006959 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.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.H3 other text : see narrative below.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE ONLY, 25 G
• 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: 17909094
• Report Number: 1213809-2023-01118
• Device Sequence Number: 6626884
• Product Code: FMI
• UDI-Device Identifier: 10612479262567
• UDI-Public: 10612479262567
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/20/2023

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: 306609
• Device Lot Number: 2006959
• 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: Not provided
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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