MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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 is reported foreign matter.Event description: material#: 305197.Batch#: 4332125.Package of sterile needles contained dead/bloody bug.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported the package of sterile needles contained a dead bug.Our quality team has completed a device history record review for material number 305197 and lot number 4332125.The review did not identify any abnormalities during the production process that could have contributed to the defect, and all quality tests were within specification.Due to the unavailability of a sample for return, a comprehensive sample investigation could not be conducted.Consequently, the exact cause of this incident remains undetermined.Should you encounter any further issues with our product, we would appreciate the opportunity to perform a detailed analysis.At this time, no further action is deemed necessary.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.A customer reported the presence of a dead insect inside a sterile needle package.To support the investigation, five sealed blister pack samples were submitted for evaluation by the quality team.During visual inspection, one of the blister packages was found to contain a dead flying insect, located within the seal area between the top and bottom webs of the packaging.This condition may have occurred during the transportation process, specifically, while a shipping truck was being moved from the dock, allowing an insect to enter the area without being intercepted by pest control measures.A review of the device history record for material number 305197, lot 4332125, was conducted.No quality issues were identified during the production of this lot that could have contributed to the reported condition.Additionally, there were no related quality notifications.All manufacturing processes and final inspections were performed in accordance with specification requirements.The affected sample will be shared with production associates to raise awareness.Based on the analysis of the returned sample, the customer¿s reported issue has been confirmed.

• Brand Name: NEEDLE 16X1 RB
• 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: 22811978
• Report Number: 1911916-2025-00584
• Device Sequence Number: 12712473
• Product Code: FMI
• UDI-Device Identifier: 00382903051977
• UDI-Public: (01)00382903051977(17)300131(10)4332125
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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: 305197
• Device Lot Number: 4332125
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 09/11/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown