MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305196
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305196.Batch # 4212625.Verbatim: rcc received a complaint via email.We have 6 boxes of needles sequestered.They appear to have a residue that pops off during use.Customer response on (b)(6)2025.1.Can you please provide an exact date of event? noticed anomaly on 2-13-2025 - sequestered inventory.2.Can you please provide the lot number associated with reported issue? 4212625.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Unknown.
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4).Follow up : it was reported there is residue that pops off during use.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were received for evaluation by our quality team.One photo shows a needle assembly in a packaging blister; the needle hub has an epoxy drip over.The second photo shows a white particle on a dark colored surface.No other information could be obtained from the photos.The epoxy on the needle hub occurs during the assembly process when there is a jam at the cannulator.A device history record review was completed for provided material number 305196, lot 4212625.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the cannulator was performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported there is residue that pops off during use.To aid in the investigation, sixty-five samples in sealed packaging blisters and two photos were received for evaluation by our quality team.A visual inspection was performed.Six of the samples have an epoxy drip over on the needle hub.No other defects or imperfections were observed.One photo shows a needle assembly in a packaging blister; the needle hub has an epoxy drip over.The second photo shows a white particle on a dark colored surface.No other information could be obtained from the photos.The epoxy on the needle hub occurs during the assembly process when there is a jam at the cannulator.A device history record review was completed for provided material number 305196, lot 4212625.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the cannulator was performed.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received.

• Brand Name: NEEDLE 18X1-1/2 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21412860
• Report Number: 1911916-2025-00128
• Device Sequence Number: 9455890
• Product Code: FMI
• UDI-Device Identifier: 30382903051961
• UDI-Public: (01)30382903051961(11)240730(17)290930(10)4212625
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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,Followup
• Report Date (Section B): 03/12/2025

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: 305196
• Device Lot Number: 4212625
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 03/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/04/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown