MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 19GA 1IN TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305186
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: one photo was provided for evaluation.The photo shows five packaging blisters top web.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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 lot # 22009 for this type of defect or symptom.There was no documentation for this type of defects during the entire production run of this batch.Based on the investigation and with no sample analysis the symptom reported by the customer can¿t be confirmed nor this symptom be correlated with a potential cause linked to the manufacturing process.This is the 1st complaint.This lot was produced for 1.9mm units; this is a cpm of 0.5; we will continue monitoring the complaints of this product and lot.Root cause description: based on the investigation and with no sample analysis the symptom reported by the customer can¿t be confirmed nor this symptom be correlated with a potential cause linked to the manufacturing process.Rationale: capa not required at this time.
Event or Problem Description
It was reported that an unspecified number of needle 19ga 1in tw experienced leakage during use.The following information was provided by the initial reporter: material no: 305186, batch no: 0022009.Received an email from the customer, providing the following information.The customer confirmed they are using a bd needle.The photo sample was provided with ref305186.The leaking was found out when the needle was dripping after removing the needle from the bag that was being filled; the clamp was open.The location of the dripping was from the tip of the needle.No further information provided.

• Brand Name: NEEDLE 19GA 1IN TW
• 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: 10199718
• Report Number: 1911916-2020-00585
• Device Sequence Number: 2108341
• Product Code: FMI
• UDI-Device Identifier: 30382903051862
• UDI-Public: 30382903051862
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2025
• Device Model Number: 305186
• Device Catalogue Number: 305186
• Device Lot Number: 0022009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/26/2020
• 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