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	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, 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
It is reported coring.Event description: we are having some quality issues with our blunt needle, mfg id 305180.When making a draw through a rubber cap we are occasionally getting chunks of rubber breaking off.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported that during needle draws through a rubber cap, rubber fragments occasionally break off.To support the investigation, two unblistered samples and three photographs were submitted for evaluation by the quality team.One of the samples was received without a plastic shield.A visual inspection was conducted using 30x magnification.No damage, grinding defects, or hook anomalies were observed.The bevels and etching appeared to be within specification.The provided photographs depict a needle assembled to a syringe, inserted into a vial.Particulate matter was visible in both the vial and the syringe; however, no additional information could be extracted from the images.A device history record (dhr) review was completed for material number 305180, lot 5064188.The review did not identify any quality issues during production that could be linked to the reported condition.No related quality notifications were found, and all processes and final inspections were performed in accordance with specification requirements.To date, no similar complaints have been reported for this lot.Based on the investigation and analysis of the submitted photographs, the reported symptom has been confirmed.However, no defects were identified in the returned physical samples.

• 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: 22952152
• Report Number: 1911916-2025-00632
• Device Sequence Number: 13140384
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 09/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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