MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305109
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported needle through shield.Event description: material#: 305109.Batch#: 3179204.Went to clean up after a procedure and grabbed the capped needle which was exposed/pierced through the cap causing a needle stick.Additional information: patient had to be called back into the office to have labs drawn, clinician had to also have labs drawn.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported that the customer grasped a recapped needle that had pierced through its protective cap.To support the investigation, three photographs were submitted and reviewed by the quality team.The images depict a needle with its plastic shield assembled onto a syringe, with the needle tip visibly protruding through the shield.No additional defects or abnormalities were observed.It is possible that the product was not used as intended, as recapping needles is not recommended practice.A device history record (dhr) review was conducted for material number 305109, lot 3179204.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.No related quality notifications were found.All manufacturing processes and final inspections were performed in accordance with specification requirements.Based on the investigation and photographic evidence, the reported condition has been confirmed.

• Brand Name: NEEDLE 27X1/2 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: 22921545
• Report Number: 1911916-2025-00623
• Device Sequence Number: 9235782
• Product Code: FMI
• UDI-Device Identifier: 00382903051090
• UDI-Public: (01)00382903051090(17)280831(10)3179204
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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: 305109
• Device Lot Number: 3179204
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown