MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32GA 4MM 100 BX 1200 CA; PEN NEEDLE

Catalog Number 320144

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 02/25/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for clog on lot # 8157552.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Investigation conclusion: as no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the pen ndl 32ga 4mm 100 bx 1200 ca experienced an inability to deliver insulin during use.The following information was provided by the customer: verbatim: ¿material no.320144 batch no.8157552.It was reported that needles only inject half of dosage and have to change needle to complete injection.Verbatim: i am diabetic and use bd ultra fine needles and want to tell you that some of my needles in lot number 8157552 only inject half of my insulin.Then i have to put another needle on the pen to inject the rest of the insulin.Is there anything that can be done about this.I don't like having to inject myself twice to get my insulin and i cant afford to use more needles than i have to.I still have the needles that plugged up.Thank you¿.See pr for additional details.Complaint summary detail: this complaint is mdr reportable.The intended use of the device is to deliver insulin/medication which did not occur.This event could lead to hyperglycemia, serious injury or harm.Event type: unable to deliver insulin/medication (during injection) / malfunction.

• Brand Name: PEN NDL 32GA 4MM 100 BX 1200 CA
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8412917
• MDR Text Key: 142624019
• Report Number: 9616656-2019-00231
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 320144
• Device Lot Number: 8157552
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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