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

Catalog Number	305197
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported white spot on the 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.E4.The initial reporter also notified the fda on 06-feb-2026.Medwatch report is mw5183724.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation a complaint was received reporting the presence of a white spot on the needle.To support the investigation, one sample with opened blister packaging was provided to the quality team for evaluation.A visual inspection of the sample identified an epoxy drip located approximately 5 16 inch from the top of the needle hub.No additional defects or irregularities were observed.This condition may occur as a result of a jam at the cannulator.A review of the device history record was conducted for material number 305197, lot 5315344.The review did not identify any quality issues detected during production that could be associated with the reported condition.No related quality notifications were identified, and all manufacturing processes and final inspections were confirmed to have met specification requirements.Verification of the cannulator was also performed, confirming that the settings were correct and product flow was consistent.To date, no additional similar complaints have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition has been confirmed.

• Brand Name: PRECISIONGLIDE
• 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: 24650683
• Report Number: 1911916-2026-00131
• Device Sequence Number: 13210698
• Product Code: FMI
• UDI-Device Identifier: 00382903051977
• UDI-Public: (01)00382903051977(10)5315344
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/08/2026

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: 305197
• Device Lot Number: 5315344
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown