MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD¿ PRECISIONGLIDE¿; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305129
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
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 a bd¿ precisionglide¿ had a needle tip that was covered in white material.
Event or Problem Description
It was reported that a bd¿ precisionglide¿ had a needle tip that was covered in white material.
Additional Manufacturer Narrative
Investigation: one sample was received for evaluation.It has drip over of white epoxy on the tip of the needle therefore failure mode is verified.An epoxy dripover generally occurs when the epoxy applicator fails to shut off for a missing cannula.There are several contributing / possible factors.A dirty sensor that doesn¿t shut the epoxy off for a missing cannula.The epoxy pressure is too high.The epoxy applicator needs attention ¿ it isn¿t shutting off when it should.The epoxy viscosity is also related to temperature fluctuations.If the temperature goes up, the epoxy gets thinner and flows faster.Here are the things we've done to improve epoxy splatters and dripovers: re-trained operators on 8feb2019 in regards to inspecting for epoxy dripovers and identify epoxy issues modified the line to prevent mis-assembled cannula from accumulating and causing epoxy on the caterpillar belts and other needles revised the visual instruction for epoxy application to assist the operators in adjusting the adhesive camera.The adhesive camera is used to assist the assembly associate with epoxy adjustments in regards to epoxy location.It is not used to disposition product.While these actions reduce the interaction required for the operator in regards to epoxy application, it is still dependent on the operator to continuously monitor the assembly process for epoxy issues.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

• Brand Name: BD¿ PRECISIONGLIDE¿
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8341884
• Report Number: 1911916-2019-00171
• Device Sequence Number: 1954859
• Product Code: FMI
• UDI-Device Identifier: 30382903051299
• UDI-Public: 30382903051299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 305129
• Device Lot Number: 7264692
• Initial Date Received by Manufacturer: 09/21/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other