MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE

Catalog Number	305155
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter: address unavailable.Bd corporate address used.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 with the use of the bd precisionglide¿ needle there was an issue with foreign matter.There was no report of injury or medical intervention.
Event or Problem Description
It was reported with the use of the bd precisionglide¿ needle there was an issue with foreign matter.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: four photos were provided for evaluation.Three of the photos were of the packaging material.The fourth photo shows an epoxy splatter on the cannula therefore failure mode was verified.The assembly rack may have tipped during production coming in contact with wet epoxy on an adjacent rack, or a misassembled cannula may have flipped during assembly coming in contact with an adjacent needle.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.Here are the things we've done to improve epoxy splatters and dripovers: re-trained operators 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.We will continue to provide coaching and feedback to them as we become aware of issues.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.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7877674
• Report Number: 1911916-2018-00509
• Device Sequence Number: 1909677
• Product Code: FMI
• UDI-Device Identifier: 00382903051557
• UDI-Public: 00382903051557
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2018

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: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 305155
• Device Lot Number: 5239749
• Initial Date Received by Manufacturer: 08/24/2018
• Supplement Date Received by Manufacturer: 08/24/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 11/08/2018
• 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