MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27X1/2 RB; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305109
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: it is reported needle became loose form hub.Event details: material # 305109 lot # 4332075 we had a serious lab incident where the metal portion of a needle became loose at the base (see picture below) causing potential exposure to hazardous material for an employee.Fortunately, none of our employees were harmed but this caused testing delays, and we were required to report the incident per federal regulations.We still have five cases of this lot unused and was wondering if there are any known issues for this lot or a recall situation? we would at least like to report it to the manufacturer just in case.Occurrence: 1 patient impacted? no patient impact (desc.): no date of event: (b)(6) 2025.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported that the metal portion of a needle became loose at its base.As a physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, one photograph was provided and reviewed by the quality team.The image depicts a syringe with a needle assembly lacking a plastic shield.No visible defects or abnormalities were observed.A device history record (dhr) review was completed for material number 305109, lot 4332075.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the provided photograph, the reported symptom could not be confirmed.In the absence of a physical sample, a probable root cause could not be determined.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that the metal portion of a needle became loose at its base.To support the investigation, eight samples in sealed blister packaging and one photograph were provided and reviewed by the quality team.A visual inspection was conducted, and no defects or imperfections were observed.Each sample underwent needle pull force testing, with all results falling within the specified acceptance criteria.The image depicts a syringe with a needle assembly lacking a plastic shield.No visible defects or abnormalities were observed.A device history record (dhr) review was completed for material number 305109, lot 4332075.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the reported symptom could not be confirmed.

• Brand Name: NEEDLE 27X1/2 RB
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 22575423
• Report Number: 1911916-2025-00536
• Device Sequence Number: 13126014
• Product Code: FMI
• UDI-Device Identifier: 00382903051090
• UDI-Public: (01)00382903051090(17)300131(10)4332075
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/19/2025

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: 305109
• Device Lot Number: 4332075
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 08/08/2025; 08/19/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/08/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown