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

Catalog Number	305195
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
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 white substance on the needle.No patient harm.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.A white substance was reported on the needle.To support the investigation, the quality team received three photographs and three samples in opened blister packaging for evaluation, one sample from lot 5266951 and two samples from lot 5334448.A visual inspection was conducted.The two samples from lot 5334448 exhibited epoxy overflow on the needle hub, and the one sample from lot 5266951 exhibited epoxy overflow on the needle.The three photographs provided correspond to the samples received.No additional defects or imperfections were observed.This condition could occur during the assembly process if a jam occurred at the cannulator.A device history record review was completed for material number 305195 for lots 5266951 and 5334448.The review did not identify any quality issues detected during production that would be expected to contribute to the reported condition, and no related quality notifications were found.All manufacturing processes and final inspections met specification requirements.Verification of the cannulator was also performed, the settings were confirmed to be correct, and product flow was acceptable.To date, no other similar events have been reported for these lots.Based on the investigation and analysis of the returned samples, the condition reported by the customer was 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: 24674381
• Report Number: 1911916-2026-00135
• Device Sequence Number: 16023669
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(17)300930(10)5266951
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 04/10/2026

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: 305195
• Device Lot Number: 5266951
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown