MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 21X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305165
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle 21x1 rb was broken.The following information was provided by the initial reporter: material # 305165.Lot # 4354369.Rcc received a complaint via email.Patient reported that he missed his dose of cortrophin because his syringe with needle broke and he did not have extras.Patient asked for extra supplies with next order.Replacement needles and syringes sent to patient.No adverse events reported.Unknown if available for return.No further information provided.Frequency: 2 consecutive days a month.Diagnosis for use: multiple sclerosis.Pt code: 4580.Device code: 1069.Reference report: mw5179384.Additional information provided: 1.Can you please provide an exact date of events in format dd-mmm-yyyy? unknown/not provided.2.Can you please provide the material and lot number associated with reported issue? per file, lot number 4354369 and 4305135.3.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? not available.4.When was this defect observed? during or before use? what was the impact to the patient? unknown/ patient missed his dose.
Additional Manufacturer Narrative
Additional information: (h) attached medwatch.Investigation results: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.With no actual sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information.

• Brand Name: BD NEEDLE 21X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• 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: 24063079
• Report Number: 1911916-2025-00840
• Device Sequence Number: 16009166
• Product Code: FMI
• UDI-Device Identifier: 00382903051656
• UDI-Public: (01)00382903051656(17)300131(10)4354369
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: Lay User/Patient
• Device Catalogue Number: 305165
• Device Lot Number: 4354369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male