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

Catalog Number	305196
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd needle 18x1-1/2 rb needle hub was cracked / damaged.The following information was provided by the initial reporter: on 30 oct 2025, during packaging lenacapavir pq2 bn:t000526; wo2191993 , the operator observed empty blisters with missing needle in it (refer to attachment 01) while performing singulation/inspection as per wi-04814 singulation of bd needle, 18g x 1.5, precision glide (5x blister pack).The issue was immediately escalated to production, npi team and quality.During singulation and inspection, operators also observed visible damage near the needle hub (pink hub), as shown in attachment 02.According to wi-04814 any units with such visible damage identified during singulation/inspection are placed in the red tray and marked as waste.When did the incident occur? unknown.
Additional Manufacturer Narrative
(b)(4) follow up report for device evaluation post investigation findings revealed the additional failure of epoxy drip-over on the needle hub.It was reported there were empty needle blisters, blisters missing needles and visible damage near the needle hub.To support the investigation, the quality team received five samples in sealed blister packaging and two photographs.Of the five samples, one was an empty blister, three exhibited epoxy drip on the needle hub, and one showed no defects or imperfections.One photograph appears to show three empty packaging blisters; the other depicts a needle assembly with epoxy drip at the hub.No additional information could be obtained from the photographs, and no other defects or imperfections were observed in the returned samples.Epoxy drip over can occur when there is a jam at the cannulator, and empty packaging blisters can occur when there is a jam at the packaging feeder.A device history record review was completed for material number 305196, lot 4270139.The review did not identify any quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All processes and final inspections complied with specification requirements.Verification of the cannulator and packaging feeder confirmed correct settings and acceptable product flow.To date, no other similar events have been reported for this lot.Based on the investigation and the analysis of the returned samples, the customer reported symptoms have been confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Post investigation results indicate an additional failure of epoxy drip-over on the needle hub.

• 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: 23665602
• Report Number: 1911916-2025-00771
• Device Sequence Number: 13362487
• Product Code: FMI
• UDI-Device Identifier: 00382903051960
• UDI-Public: (01)00382903051960(11)240926(17)291231(10)4270139
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: Other
• Device Catalogue Number: 305196
• Device Lot Number: 4270139
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown