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

Catalog Number	305127
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
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 customer that withdrew the needle and noted a white ceramic appearing substance along the shaft, similar to the formed hardened substance at the base of the needle that adjoins the needle shaft to the blue base hub of the needle.
Additional Manufacturer Narrative
Pr (b)(4) follow up: it was reported that a white, ceramic like substance was observed along the shaft of the needle.To support the investigation, one photograph was provided to the quality team for evaluation.The image depicts a needle assembly without the packaging blister.The plastic shield has been removed, and material consistent with epoxy is visible from the mid shaft of the needle extending to the top.No additional defects or irregularities were identified.This condition could occur during the assembly process if a jam were to occur at the cannulator.A review of the device history record was conducted for material number 305127, lot 5238125.The review did not identify any quality issues during production that would have contributed to the reported condition, and no related quality notifications were associated with this lot.All manufacturing processes and final inspections were performed in accordance with specification requirements.Verification of the cannulator confirmed that the equipment settings were correct and that product flow was normal.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the photographic evidence, the condition reported by the customer is 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: 24816055
• Report Number: 1911916-2026-00160
• Device Sequence Number: 15874719
• Product Code: FMI
• UDI-Device Identifier: 00382903051274
• UDI-Public: (01)00382903051274(17)300930(10)5238125
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 305127
• Device Lot Number: 5238125
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown