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

Catalog Number	305195
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
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 # 305195 & batch # 4332115.It was reported by the customer that needle poked through plastic cap.Verbatim: rcc received a complaint via phone.Issue: needle poked throught plastic cap.Clean needle stick occurred.No, no medical or surgical intervention was required or requested.
Additional Manufacturer Narrative
(b)(4) follow up: an incident was reported in which a needle punctured the plastic cap during an attempted recapping.To support the investigation, a photograph was submitted for evaluation by our quality team.The image depicts a needle with the plastic shield assembled onto a syringe, with the needle visibly protruding through the shield.This suggests the product may have not been used as intended.It is important to note that this product is not designed to be recapped.A review of the device history record (dhr) was conducted for material number 305195, lot 4332115.The review found no quality issues during the manufacturing process that could have contributed to the reported condition.Additionally, there were no related quality notifications associated with this lot.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 submitted photograph, the customer¿s 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: 21984985
• Report Number: 1911916-2025-00332
• Device Sequence Number: 15532066
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(11)241127(17)300228(10)4332115
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 4332115
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 05/15/2025
• 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