MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305106
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle 30x1/2 rb needle hub was cracked / damaged / deformed.The following information was provided by the initial reporter: material #305106.Batch #4116510, 5091104, 4159365, 4116511, 4116509.Verbatim: rcc received a complaint via phone.Pir attached.Product complaint: ref 305106 lot 4116510, 5091104, 4159305, 4116511 issue: can draw in solution and attempting to expel air, the needle is blocked.There appears to be particles coming off the needle hub suspect that they maybe blocking the needle.(b)(6) 2025 unknown lot possibly other will provide when acknowledgement is sent.Samples: (b)(4) sample-uncontaminated.Representative samples - (b)(4).Additional information provided: it is being reported as hubs breaking apart.Outpatient neurology in (b)(6) is having an intermittant issue with the hubs breaking apart with the following needle- wrapper information is provided as well on the photos with lot number.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that the needle hubs were cracking.To support the investigation, twenty-five samples and three photographs were submitted for evaluation by the quality team.Twenty-four samples arrived in sealed blister packaging, while one sample was received without packaging.A visual inspection was conducted, revealing that the sample without packaging had a damaged needle hub.Two of the photographs provided confirmed this damage.The third photograph depicts a packaging blister top web.No other defects or imperfections were observed.Each sample was assembled with a syringe containing saline solution, and all expelled the solution with normal flow.The needle hub damage could occur if a jam occurs at the needle hub feeder.A device history record review was completed for material 305106, covering lots 4116510, 5091104, 4116511, 4159365, and 4116509.The review did not identify any quality issues during production that could have contributed to the reported condition.No related quality notifications were found, and all processes and final inspections complied with specification requirements.Verification of the needle hub feeder confirmed that the settings were correct, and product flow was satisfactory.Based on the investigation and analysis of the returned sample, the reported symptom of a damaged needle hub has been confirmed.

• Brand Name: BD PRECISIONGLIDE
• 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: 23622101
• Report Number: 1911916-2025-00757
• Device Sequence Number: 18404966
• Product Code: FMI
• UDI-Device Identifier: 00382903051069
• UDI-Public: (01)00382903051069(17)290630(10)4116510
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 305106
• Device Lot Number: 4116511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown