MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 19GA 1IN TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305186
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 needle 19ga 1in tw had what appeared to be an excessive white compound that had dripped down the needle.The white compound attaches/seals the needle into the brown connector.
Event or Problem Description
It was reported that a needle 19ga 1in tw had what appeared to be an excessive white compound that had dripped down the needle.The white compound attaches/seals the needle into the brown connector.
Additional Manufacturer Narrative
Investigation: one sample and one photo were received for evaluation.The sample has a white epoxy drip over on the plastic shield.The epoxy got also stuck to the plastic shield.The photo shows the defect found on the sample.Failure mode is verified.An epoxy drip over 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.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: NEEDLE 19GA 1IN TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8374357
• Report Number: 1911916-2019-00222
• Device Sequence Number: 16248194
• Product Code: FMI
• UDI-Device Identifier: 30382903051862
• UDI-Public: 30382903051862
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (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): 03/06/2019

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: 02/28/2023
• Device Catalogue Number: 305186
• Device Lot Number: 7361735
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/07/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/06/2019
• 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