MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27GA 1-1/2IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	301629
Medical Device Problem Codes	Leak/Splash (1354); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description: it was reported by the customer that the needle started leaking part way up the hub.Verbatim: rcc received a complaint via email.Material: 301629.Batch#: 2175224.We were using bd precisionglide needle 27g x 1 1.5, the needle started leaking part way up the hub.Additional information the date of the event was 5/21/25, unable to provide physical sample as it was used on a patient and a dirty needle.Will send picture of needle and where it was leaking from circled in black (included in this email).No adverse effects noted.
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 mdr for correction annex code updated to a041001.Date received by manufacturer: 06/09/2025.Device evaluation: it was reported that the needle began leaking near the upper portion of the hub.As the physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, a single photograph was provided for review by our quality team.The image depicts a needle assembly with the plastic shield removed from its packaging blister.A dark-colored circular mark is visible from the center to the upper area of the needle hub.No additional information could be discerned from the photograph.A review of the device history record (dhr) was completed for material number 301629, lot 2175224.The review found no quality issues during the production of this lot that could be linked to the reported condition.Additionally, there were no related quality notifications.All manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar incidents have been reported for this lot.Based on the investigation and the limited photographic evidence, the reported issue could not be confirmed.Without the return of the physical sample, it is not possible to determine a probable root cause.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE 27GA 1-1/2IN
• 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: 22122488
• Report Number: 1911916-2025-00388
• Device Sequence Number: 19860931
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: (01)30382903016298(11)220624(17)271031(10)2175224
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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
• 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: 301629
• Device Lot Number: 2175224
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown