MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305180
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material # 305180.Lot # 4178029.Verbatim: numerous reports of blunt fill needles causing coring of vials when drawing up meds customer response received on (b)(6) 2025.This was initially observed two weeks ago (b)(6) 2025; however, the majority of the reports began occurring (b)(6).I have ~20 involved needles along with the impacted medication.No impact to patients.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported blunt fill needles causing are coring of vials when drawing up meds.To aid in the investigation, twelve samples in opened packaging blisters, two syringes and two photos were received for evaluation by our quality team.A visual inspection was performed with 30x magnification to the needles returned.There was no damage, defective grind or hooks observed.The bevels and etch were good.One syringe returned is 20ml and the second syringe returned is 3ml.Each syringe has a particle adhered to the rubber stopper.One is gray and the other is light red.The two photos provided show a syringe with a particle in solution.A device history record review was completed for provided material number 305180, lot 4178029.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.The blunt fill needles have no defects or imperfections.
Event or Problem Description
Date of event: this was initially observed two weeks ago ~(b)(6) 2025; however, the majority of the reports began occurring 1/16.
Additional Manufacturer Narrative
B3: date of event 16january 2025.

• Brand Name: NEEDLE 18X1-1/2 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: 21270019
• Report Number: 1911916-2025-00055
• Device Sequence Number: 4417342
• Product Code: GAA
• UDI-Device Identifier: 30382903051800
• UDI-Public: (01)30382903051800(11)240626(17)290930(10)4178029
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2025

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: 305180
• Device Lot Number: 4178029
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: Not provided; 02/07/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown