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

Catalog Number	305145
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/26/2018
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 before use of the bd precisionglide¿needle "there is a crusty white coating on the syringe." there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: investigation results: not applicable; no samples or photos were attached.Qn review: no notifications written for fm for this batch, nor for the associated assembly batch.Dhr review: needle assembly batch 6056562 had 15 visual inspections performed on (b)(4) parts with zero defects recorded.Assembly batch 5303547 had seven visual inspections performed on (b)(4) parts with zero defects recorded.Investigation conclusion: possible root cause: unable to determine.
Additional Manufacturer Narrative
Additional information: investigation results: one sample was returned.It has epoxy on the tip of the needle.Possible root cause: the rack of needles fell against another rack coming in contact with uncured epoxy.A misassembled needle with uncured epoxy came into contact with the needles in question during assembly.Corrective action: here are the things we've done to improve epoxy splatters and drip overs: re-trained operators in regards to inspecting for epoxy drip overs 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.

• 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: 7275378
• Report Number: 1911916-2018-00035
• Device Sequence Number: 1741824
• Product Code: FMI
• UDI-Device Identifier: 30382903051459
• UDI-Public: 30382903051459
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2018

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: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 305145
• Device Lot Number: 6055999
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 01/29/2018; 01/29/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 03/12/2018; 04/25/2018
• 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