MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Description: it was reported by customer they found black mold.Verbatim: material #305195 lot #4354089 customer states that they found black mold in the syringe and some moisture.They found it before it was used on a patient.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.A report was received indicating the presence of black mold and moisture.To support the investigation, one sample, contained in an opened blister package, was submitted for evaluation by the quality team.A visual inspection was conducted using 10x magnification.The plastic shield exhibited dark-colored particles, identified as embedded degraded resin, along with an air bubble resulting from the molding process.No additional defects or imperfections were observed.The presence of degraded resin is typically associated with startup conditions or intermittent occurrences during the injection molding process.During these times, degraded resin may become dislodged and incorporated into molded components.The sample was submitted to a laboratory for further analysis, which confirmed that the foreign material was not mold, but embedded degraded resin.A device history record (dhr) review was completed for material number 305195, lot 4354089.The review found no quality issues during the production of this lot that could have contributed to the reported condition.Additionally, no related quality notifications were identified.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 analysis of the returned sample, the customer-reported condition has been confirmed.

• Brand Name: NEEDLE 18X1 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: 22410754
• Report Number: 1911916-2025-00484
• Device Sequence Number: 13179907
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(17)300331(10)4354089
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: 305195
• Device Lot Number: 4354089
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown