MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 26X3/8 IB; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305110
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the needle came apart from the syringe.As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Material #: 305110 batch#: unknown it was reported by customer that while filling a new cartridge, the needle came apart from the syringe.Verbatim: rcc received a complaint via email.Email(s) attached.¿ caller reported while filling a new cartridge, the needle came apart from the syringe.¿ with how many syringes/needles did the caller experience the issue? ¿ one ¿ was the syringe/needle reused? - no ¿ product with issue - bd 26 g, 3/8" needle, pn 305110.¿ product lot # - unavailable ¿ did issue cause any injury? - no ¿ how did the caller resolve the issue? ¿ changed syringe and needle and successfully filled a cartridge with insulin.Resolution ¿ no further tandem follow up is required.This report represents all available product information.No additional information is available.No closure letter is required for complaints where we are not returning samples for analysis.
Additional Manufacturer Narrative
(b)(4) correction.Following the submission of the initial mdr, it has been determined that the previously submitted report was sent in error, and the complaint will be cancelled.The associated mdr will be void.

• Brand Name: NEEDLE 26X3/8 IB
• 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: 21719976
• Report Number: 1911916-2025-00252
• Device Sequence Number: 14435349
• Product Code: FMI
• UDI-Device Identifier: 30382903051107
• UDI-Public: (01)30382903051107
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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: 305110
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female