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

Catalog Number	306616
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 306616, lot # 2202914.It was reported that the bd safetyglide needle was clogged / blocked.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Vaccine would not advance in needle.Lot number - 2202914.Additional information provided: 1) please provide date of event? 2)any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? 3).Please share the captured photo of the event if available.4) any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.1.11/1/2024.2.We have the box of needles, but the used needle was placed in the sharps container afterwards.3.I do not have a photo of the incident or the needle.I do have a photo of the box the needle came from.4.No injury or adverse event to patient or healthcare professional.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4): supplemental mdr - needle clogged/blocked.Thirty-eight 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.All the samples expelled the solution with normal flow, clogged needle was not confirmed.Furthermore, a device history record review was completed for provided batch number 2202914.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.Based on the investigation and with the sample analysis the symptom reported could not be confirmed.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20875238
• Report Number: 1213809-2024-00926
• Device Sequence Number: 8905113
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598(11)220721(17)270630(10)2202914
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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: Health Professional
• Device Catalogue Number: 306616
• Device Lot Number: 2202914
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/08/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown