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	07/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 306616 batch # 2188470 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.Email(s) attached.Seems to be a blockage in the needles as when the attempt to give shots, the fluids do not come through lot / serial number (b)(6) complaint number (b)(4).Additional information provided: 1.Since the needle did not allow the vaccine to go through, we had to get another needle and stick the patient again to give the vaccine.2.There is no picture of this event.Please let me know if you have any questions or need further information.
Additional Manufacturer Narrative
(b)(4).Supplemental mdr - needle clogged/blocked.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.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
No additional information was provided.

• 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: 19997075
• Report Number: 1213809-2024-00550
• Device Sequence Number: 7201399
• Product Code: FMI
• UDI-Device Identifier: 10612479262598
• UDI-Public: (01)10612479262598
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 2188470
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown