MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 26X3/8 IB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305110
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Description: it was reported by customer, medication to splash out when trying pull out for administration.Pt's (patient's) mother reported the needles received were bent which then caused all the medication to splash out when trying pull out for administration.Unknown if patient has missed dose.Unknown if patient experienced an adverse event as a result.Unknown if patient has defective product on hand.Unknown product lot number and expiration date.Item#: 305110.
Additional Manufacturer Narrative
(b)(4) follow up 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.

• Brand Name: NEEDLE 26X3/8 IB
• 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: 22436367
• Report Number: 1911916-2025-00507
• Device Sequence Number: 19991424
• Product Code: FMI
• UDI-Device Identifier: 00382903051106
• UDI-Public: (01)00382903051106
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown