MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 27X1-1/4 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305136
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	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported, hole in the needle hub.Material: 305136.Batch: 2021694.While testing a syringe for break loose glide force using a bd needle, liquid was seen extruding through a hole in the needle hub as well as the needle during testing.Additional information: the needle was used during break loose glide force testing.The result of that test is invalid due to the defect in the needle.
Additional Manufacturer Narrative
(b)(4).Follow up.The customer reported that liquid was observed extruding through a hole in the needle hub.Because the physical sample was not returned, a comprehensive evaluation could not be performed.To support the investigation, two photographs were provided for review by the quality team.The images show a needle assembled to a syringe.One image, taken under magnification, includes a dark arrow indicating what appears to be a hole in the needle hub.No additional information could be obtained from the photographs.A review of the device history record for material number 305136, lot 2021694, identified no quality issues during production that could have contributed to the reported condition.There were no related quality notifications, and all processes and final inspections were in compliance with specification requirements.Based on the investigation and the photographic evidence, the reported symptom is confirmed.However, in the absence of the physical sample, a probable root cause could not be determined.
Additional Manufacturer Narrative
(b)(6) follow up for device evaluation.The customer reported observing liquid extruding through a hole in the needle hub.To support the investigation, one unblistered sample and two photographs were provided for review by the quality team.A visual inspection of the sample identified a pinhole located approximately 7 32 inch from the bottom of the needle hub.The sample was assembled to a syringe filled with saline solution and tested, at which point fluid was observed expelling not only through the needle, but also through the pinhole.The photographs depict a needle assembled to a syringe, with one magnified image showing a dark arrow indicating what appears to be a hole in the needle hub.No additional information could be obtained from the images.Previous investigations have determined that wear of the stripping bushing within the molding tool could contribute to this condition, and corrective action was implemented through installation of a new stripping bushing.A review of the device history record for material number: 305136, lot: 2021694, identified no quality issues during manufacturing that could have contributed to the reported condition.No related quality notifications were documented, and all manufacturing processes and final inspections were completed in compliance with applicable specifications.At the time of this review, no other similar events have been reported for this lot.Based on the investigation results, including evaluation of the physical sample and photographic evidence, the reported symptom is confirmed.

• Brand Name: NEEDLE 27X1-1/4 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 24047866
• Report Number: 1911916-2026-00005
• Device Sequence Number: 18578132
• Product Code: FMI
• UDI-Device Identifier: 30382903051367
• UDI-Public: (01)30382903051367(17)270430(10)2021694
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/24/2026

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: 305136
• Device Lot Number: 2021694
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/27/2026; 03/24/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 01/27/2026; 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown