MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16GX1-1/2IN RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305198
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305198, batch#: 5056705.It was reported by customer that the shaft of the needle is completely separating from the hub."we use quite a large amount of the #: 305198 16g 1.5" needles for sterile compounding - this week there has been a number of reports of these needles breaking in atypical fashion.The shaft of the needle is completely separating from the hub, which is a risk for needlestick injury." customer response received on 23-apr-2025.1.Can you please provide an exact date of event in this format mm-dd-yyyy? the events occurred on two different days, with two different technicians making two different compounds.The first was on or around monday 04-07-2025 and the second was on friday 04-11-2025.2.Sample availability is mentioned as yes, please check with customer and provide the address of the facility for us to ship the return label address: 3.Was there any harm to the patient/caregiver? (detail) both cases the technicians were unharmed and able to mitigate a needlestick injury.
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)(4) follow up for device evaluation: it has been reported that the shaft of the needle is completely separating from the hub.To assist in the investigation, two samples, with one opened packaging blister one plastic shield, were received for evaluation by our quality team.A visual inspection revealed that the needles are loose from the needle hub.Both units have approximately 30% of the epoxy applied to secure the needle to the hub.No other defects or imperfections were observed.This condition may occur if there is a jam at the cannulator during the manufacturing process.A device history record review was conducted for material number 305198, lot 5056705.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.Verification of the cannulator was performed, confirming that the settings were correct and the flow of product was satisfactory.Based on the investigation and analysis of the returned samples, the symptom reported by the customer has been confirmed.

• Brand Name: NEEDLE 16GX1-1/2IN 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: 21909685
• Report Number: 1911916-2025-00306
• Device Sequence Number: 8729063
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985(11)250228(17)300131(10)5056705
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2025

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: 305198
• Device Lot Number: 5056705
• 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: 04/11/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown