MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1IN BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305181
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation a black speck, suspected to be caused by rubber coring, was reported in a vial.To support the investigation, one hundred samples in sealed blister packaging were submitted for evaluation by the quality team.A visual inspection was conducted using 30x magnification.No damage, defective grinding, or hook anomalies were observed.The bevels and etching were found to be within acceptable standards.A review of the device history record (dhr) was completed for material number 305181, lot 4116544.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.Additionally, no related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.Based on the investigation and analysis of the returned sample, the reported issue could not be confirmed.
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.
Event or Problem Description
Material: 305181 batch#: 4116544 it was reported by the customer that there was a black speck in the vial from the rubber coring when drawing up the medication.Verbatim: ¿event: we had two different clinicians draw up lidocaine xxx (multidose vial) 1% lot # hn6899 exp 11/1/25.After each clinician drew up the lidocaine at a 90 % angle with two different vials, there was a black speck in the vial from the rubber coring when drawing up the medication.A bd blunt fill needle 18gx1in was used to draw up the medication.Lot # 4116544 exp 8/31/29.¿ additional information lot # 4116544 exp 8/31/29 bd blunt fill needle 18g 1in no patient harm or injury - rubber particle in the medication after puncturing the vial.

• Brand Name: NEEDLE 18X1IN BLUNT FILL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 21960549
• Report Number: 1911916-2025-00322
• Device Sequence Number: 9252866
• Product Code: GAA
• UDI-Device Identifier: 30382903051817
• UDI-Public: (01)30382903051817(11)240425(17)290831(10)4116544
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• 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): 05/22/2025

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: 305181
• Device Lot Number: 4116544
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 05/27/2025
• 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