MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305128
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305128.Batch#: 1335520.It was reported by customer that the needle came apart from hub where it is normally glued in place.Verbatim: please see product complaint from below, please report at once.Any known issues with the lot number below? internal documentation: (b)(4).Date of event 3/4/2025.Site: (b)(6).Department: urgent care.No harm to patient.Description: needle came apart from hub where it is normally glued in place.Leader notified (b)(6) to determine what to do with box.Box removed from inventory.
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.
Additional Manufacturer Narrative
(b)(6).Follow up for device evaluation.It was reported the needle came apart from hub.To aid in the investigation, seventy-nine samples in sealed packaging blisters and one photo was received for evaluation by our quality team.A visual inspection was performed on the physical samples, and no defects or imperfections were observed.The epoxy applied to the needle-needle hub joint was acceptable.Twenty samples were randomly selected for a needle pull force test.The results were within specification.The photo shows a needle assembly with no packaging and the plastic shield removed.The needle has epoxy, but the needle is separated from the needle hub.No other information could be obtained from the photo.A device history record review was completed for provided material number 305128, lot 1335520.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation with the photo sample analysis the symptom reported by the customer is confirmed but could not be reproduced or observed in the representative samples returned.

• Brand Name: NEEDLE 30X1 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: 21751866
• Report Number: 1911916-2025-00256
• Device Sequence Number: 8236074
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282(11)211201(17)270430(10)1335520
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 04/10/2025

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: 305128
• Device Lot Number: 1335520
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown