MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 23X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.\ h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305902 batch # 2318924, unknown it was reported that the bd needle sftygld 23x1 rb needle was clogged / blocked.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached issue with 305902, lot 2318924 ¿rn was to administer 80 mg of im methylprednisolone with a 3 ml syringe and a 23 g 1 inch needle.Half of the medication was administered then i met resistance.I retracted the syringe with the needle still attached the medication would not advance, when i removed the needle, the medication would advance through the syringe.I had to administer two separate injections.This also happened on another patient with the same medication and syringe/needle type.¿ additional information provided: 1.Only impact to the patient was that they received two injections 2.No adverse effects from the incident 3.The date it occurred was the date the midas event was placed.I am unable to recall the first patient and we see anywhere that from 90-100 patients a day so it is hard for me to recall the patient information 4.No sample or photo.
Additional Manufacturer Narrative
No samples or photos received by our quality team for evaluation.Furthermore, a device history record review was completed for provided batch number 2318924.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Previous investigations have revealed that 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.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SFTYGLD 23X1 RB
• 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: 20754020
• Report Number: 1213809-2024-00864
• Device Sequence Number: 13084388
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028(11)221114(17)271031(10)2318924
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 12/09/2024

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: 305902
• Device Lot Number: 2318924
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown