MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1-1/2 BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number	305180
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported by the customer that small white plastic adhered to end of needle.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.The customer reported observing a small white plastic material adhered to the end of the needle.To support the investigation, the quality team received one sample with the blister packaging opened for evaluation.A visual inspection identified an epoxy drip on the needle approximately 7,8 inch from the top of the needle hub.No additional defects or abnormalities were observed.This condition could result during the assembly process if a jam were to occur at the cannulator.A device history record review was completed for material number 305180, lot 5303695.The review did not identify any quality issues detected during production of this lot that would have contributed to the reported condition, and no related quality notifications were found.All manufacturing steps and final inspections were performed in accordance with applicable specifications.Verification of the cannulator was also completed, the settings were confirmed to be correct and product flow was acceptable.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition is confirmed.

• Brand Name: NEEDLE 18X1-1/2 BLUNT FILL
• Common Device Name: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• 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: 24776496
• Report Number: 1911916-2026-00147
• Device Sequence Number: 9987827
• Product Code: GAA
• UDI-Device Identifier: 00382903051809
• UDI-Public: (01)00382903051809(11)251030(17)301031(10)5303695
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• 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): 04/09/2026

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: Health Professional
• Device Catalogue Number: 305180
• Device Lot Number: 5303695
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 04/03/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown