MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 30GA 7/8IN BSG CLEAR HUB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	302890
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: n/a.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 there was "excess of epoxy" on the needle 30ga 7/8in bsg clear hub.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
Dhr review: batch 7261545 had ten visual inspections performed on 650 parts with zero defects noted.The id inspection system was challenged six times using 150 parts with zero failures noted.Dripover: 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.The epoxy stain on the cannula is where the epoxy is applied, and then runs down to fill the epoxy well on the hub.Other than the dripover, the defect could not be confirmed as reported.All product measured was within specification limits.
Event or Problem Description
It was reported that there was "excess of epoxy" on the needle 30ga 7/8in bsg clear hub.There was no report of exposure, injury, or medical intervention.

• Brand Name: NEEDLE 30GA 7/8IN BSG CLEAR HUB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8018946
• Report Number: 1911916-2018-00597
• Device Sequence Number: 1380772
• Product Code: FMI
• UDI-Device Identifier: 50382903028905
• UDI-Public: 50382903028905
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2018

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 Catalogue Number: 302890
• Device Lot Number: 7261545
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/17/2018
• 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