MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD PEN NDL 32G 4MM HP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320550

Device Problem Defective Device (2588)

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

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

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 does not attach/detach & harm skin irritation on lot # 9044773.Investigation summary: no samples 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 conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.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 hub is difficult to attach to pen with a bd pen ndl 32g 4mm hp.The following information was provided by the initial reporter: (1 of 2 complaints) reported the hub does not fit the pen easily, it takes longer to attach it on the pen.She has to take insulin once a day.Consumer stated her pharmacy stated we have discontinued the regular nano.She visually does not test the needle to see if it is straight.Advised we recommended to see the needle to see if it is straight.She firmly attaches the pen needle on to the pen.Consumer does not do priming, explained we recommend to do the priming each time.

• Brand Name: BD PEN NDL 32G 4MM HP
• 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: 9510763
• MDR Text Key: 194151779
• Report Number: 9616656-2019-01263
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 12/10/2019

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: 02/29/2024
• Device Catalogue Number: 320550
• Device Lot Number: 9044773
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• 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