MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 21X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305167
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2025
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
Issue: the certificate of compliance has the expiration date different from what is printed on the package.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that the reported event was not reportable to the fda as it is not likely to cause or contribute to serious injury or death.If we receive any information that changes this decision, another follow up mdr will be submitted.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE 21X1-1/2 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: 22507149
• Report Number: 1911916-2025-00514
• Device Sequence Number: 9246539
• Product Code: FMI
• UDI-Device Identifier: 00382903051670
• UDI-Public: (01)00382903051670(17)300331(10)5064179
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 07/21/2025

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: 305167
• Device Lot Number: 5064179
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown