MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 26X3/8 IB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305110

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed.Therefore, a potential root cause(s) cannot be determined.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: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of syringe needle connectivity issue for lot #9029658 item #305110.Related complaint: (b)(4).A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Root cause description: based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed.Therefore, a potential root cause(s) cannot be determined.

Event Description

It has been reported that the bd¿ needle 26x3/8 ib has been found experiencing two occurrences of difficulty to connect the needle and syringe during use.The following has been provided by the initial reporter: it was reported the customer had a difficult time screwing the needle onto the syringe resulting in insulin leaking out of the hub.Description of issue: (1) customer had a hard time screwing the needle onto the syringe (2) customer reported insulin leaking out of orange hub component of needle.Number of occurrences: 2.

• Brand Name: BD¿ NEEDLE 26X3/8 IB
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9534174
• MDR Text Key: 190784689
• Report Number: 1911916-2019-01343
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051107
• UDI-Public: 30382903051107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 305110
• Device Lot Number: 9029658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other