MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305156
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter additional phone #: (b)(6).Investigation summary: one photo was provided.The photo shows a needle with no plastic shield.It has white epoxy towards the middle of the needle.The plastic hub is placed under the cannulator.Then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it.In this case it is possible that a jam occurred, and the equipment dispensed silicone before the part was moved to the next station and was not detected in the next processes.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.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.Investigation conclusion: this is the 1st complaint for the lot # 9058635 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: in this case it is possible that a jam occurred, and the equipment dispensed silicone before the part was moved to the next station and was not detected in the next processes.Rationale: capa not required at this time.
Event or Problem Description
It was reported that there was epoxy discovered on needle prior to use with a bd needle 22x1-1/2 rb.The following information was provided by the initial reporter: it was reported that there was a white substance on the needle prior to any medication being injected.

• Brand Name: BD NEEDLE 22X1-1/2 RB
• 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: 9640979
• Report Number: 1911916-2020-00067
• Device Sequence Number: 19379312
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• 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
• Report Date (Section B): 01/22/2020

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: 04/30/2024
• Device Model Number: 305156
• Device Catalogue Number: 305156
• Device Lot Number: 9058635
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 01/29/2020
• 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