MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320122

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 08/14/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: level b 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 4th related complaint for needle clog on lot # 8338558.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.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 has been reported that the bd ultra-fine¿ nano¿ pen needles 4mm (5/32¿) 32g has been found experiencing 10 occurrences of inability to deliver medication during use.The following has been provided by the initial reporter: it was reported nothing comes out of the pen needle during injection.Verbatim: consumer reported nothing comes out of the pen needle during injection.Sometimes she gets partial.Sample discarded.Incident date- unknown; occurence- 10.Item# 320122; lot# 8338558; expiration date- 2023-11-30; consumer does the priming.Visually tests the needle to see if it is straight.Uses new needle each time , rotates the injection site and firmly attaches the pen needle on to the pen.

• Brand Name: BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G
• Type of Device: HYPODERMIC SINGLE LUMEN 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: 8946540
• MDR Text Key: 156124908
• Report Number: 9616656-2019-00811
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: 10885403928659
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 320122
• Device Lot Number: 8338558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2018
• 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