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

Catalog Number	305211
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that white residue on the supplied needle.
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.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation a complaint was received alleging white residue on the supplied needle.To support the investigation, one sample, received without a blister package, was provided to the quality team for evaluation.A visual inspection was performed, and no defects, imperfections, or evidence of excessive epoxy were observed on the needle or needle hub.The epoxy at the needle hub needle joint was evaluated and found to be acceptable and within product specification.A device history record review was completed for material number 305211, lot 4247119.The review did not identify any quality issues during production of this lot that would be expected to contribute to the reported condition.No related quality notifications were identified, and all manufacturing processes and final inspections met specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and evaluation of the returned sample, the condition reported by the customer could not be confirmed.
Event or Problem Description
No patient harm.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported there was a white residue on the supplied needle.Our quality team has completed a device history record review for material number 305211 and lot number 4247119.The review did not identify any abnormalities during the production process that could have contributed to the condition, and all quality tests were within specification.Due to the unavailability of a sample for return, a comprehensive sample investigation could not be conducted.Consequently, the exact cause of this incident remains undetermined.Should you encounter any further issues with our product, we would appreciate the opportunity to perform a detailed analysis.At this time, no further action is deemed necessary.

• Brand Name: NEEDLE FILTER BLUNT FILL 18X1-1/2
• 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: 24789715
• Report Number: 1911916-2026-00153
• Device Sequence Number: 9900863
• Product Code: GAA
• UDI-Device Identifier: 00382903052110
• UDI-Public: (01)00382903052110
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 05/01/2026

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: 305211
• Device Lot Number: 4247119
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 05/01/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/30/2026; 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown