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

Catalog Number	305136
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported there is white glue residue at hub of needles.To aid in the investigation, six samples with no packaging blisters and one photo was provided for evaluation by our quality team.A visual inspection was performed and the needles have an epoxy drip over on the needle hub.The photo provided shows two needle assemblies with no packaging blisters.They both have the plastic shield and an epoxy drip over on the needle hub.No other defects or imperfections were observed.This defect could occur during the assembly process.During manufacturing, the plastic hub is placed under the cannulator, then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.After, a plastic shield is assembled.In this case, a jam may have occurred at the cannulator inducing the epoxy drip over on the needle hub.A device history record review was completed for provided material number 305136, lot 2117337.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The samples will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is 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.H3 other text : see h10.
Event or Problem Description
It was reported that 100 bd precisionglide¿ needles had glue-like, foreign residue on their hubs.The following information was provided by the initial reporter: "approximately 100, to date, have white glue residue at the hub of the needles.".

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16317091
• Report Number: 1911916-2023-00056
• Device Sequence Number: 7992781
• Product Code: FMI
• UDI-Device Identifier: 00382903051366
• UDI-Public: 00382903051366
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/20/2023

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: 305136
• Device Lot Number: 2117337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown