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

Catalog Number	305198
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd precisionglide hypodermic needle experienced epoxy on needle.The following information was provided by the initial reporter: lab techs are having issues with the 16 gauge and 18 gauge needles in the lab.There seems to be excessive glue holding the needle parts together.The glue is occasionally flaking off the needle and landing in the compounding area.I don't have a lot of info about lot and expiration.I was told it happens more with the purple 16 gauge needles than the pink 18 gauge needles.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 16mar2023.H6: investigation summary: it was reported there is excessive glue holding the needle parts together.To aid in the investigation, two samples in opened packaging blisters and one photo was provided for evaluation by our quality team.A visual inspection was performed.One sample has an epoxy drip over on the needle hub, the other sample has no defects or imperfections.The photo provided shows the sample received with the epoxy drip over on the needle hub.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 305198, lot 2144497.The review revealed there was documentation for this type of defect during the production run of this batch.A quality notification was documented.Verification of the cannulator was performed.The settings were correct, and the flow of product was good.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
It was reported that the bd precisionglide hypodermic needle experienced epoxy on needle.The following information was provided by the initial reporter: lab techs are having issues with the 16 gauge and 18 gauge needles in the lab.There seems to be excessive glue holding the needle parts together.The glue is occasionally flaking off the needle and landing in the compounding area.I don't have a lot of info about lot and expiration.I was told it happens more with the purple 16 gauge needles than the pink 18 gauge needles.

• Brand Name: BD PRECISIONGLIDE HYPODERMIC 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16540706
• Report Number: 1911916-2023-00137
• Device Sequence Number: 7324621
• Product Code: FMI
• UDI-Device Identifier: 00382903051984
• UDI-Public: (01)00382903051984
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 03/17/2023

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: Health Professional
• Device Catalogue Number: 305198
• Device Lot Number: 2144497
• 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: 02/20/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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