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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 305110, batch#: unknown.It was reported by the customer that they loaded the needle into the cartridge, the insulin came out of the side of the needle instead of into the cartridge.Verbatim: rcc received a complaint via email.Caller reported that when they loaded the needle into the cartridge, the insulin came out of the side of the needle instead of into the cartridge.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, (b)(6).Is product available for return to bd? ¿ yes.Cts informed caller bd might follow up regarding return of syringe/needle.Caller acknowledged.Xxxx.Product lot # - [230405].Did issue cause any injury? - no.How did the caller resolve the issue? ¿ changed needle only and successfully filled a cartridge with insulin.Resolution ¿ no further tandem follow up is required.Cts to replace the needle and syringe upon request.
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.It was reported the insulin came out the side of the needle.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.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
Pr (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, 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: 20677173
• Report Number: 1911916-2024-00808
• Device Sequence Number: 8395358
• Product Code: FMI
• UDI-Device Identifier: 30382903051107
• UDI-Public: (01)30382903051107
• 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): 06/03/2025

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: Lay User/Patient
• Device Catalogue Number: 305110
• Device Lot Number: UNKNOWN
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 01/13/2025; 06/03/2025
• Initial Report FDA Received Date: 11/13/2024
• Supplement Report FDA Received Date: 01/13/2025; 06/04/2025
• 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 Age: 70 YR
• Patient Sex: Male