MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number UNKNOWN

Device Problem Defective Device (2588)

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

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.Device manufacture date: unknown.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.Unable to perform dhr check due to an unknown lot number for does not attach as intended & does not detach as intended.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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 above, no additional investigation and no capa is required at this time.

Event Description

It was reported that the unspecified bd¿ pen needle was difficult to attach and remove from the "solostar" pen during use.Later, the consumer reportedly downloaded information online about instructions for use, and realized they were "doing it wrong" by "pulling the needle without pushing it".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "daughter of a consumer reported unable to attach the pen needle on to the pen and unable to remove the pen needle.Consumer was put on to insulin pen recently, she uses the solostar.She was only able to remove it twice.She has to go to her mothers house to help her remove it manually, she has to try about 10 times.And twice she pricked her finger while removing the pen needle manually.Didn't bleed.She didn't do nothing.Forgot to add, mother is also having an issue attaching and to removing the pen needle." "followed up with the caller.She stated after she went home she went to a website, downloaded the information to see the instruction.She realized she was doing it wrong by pulling the needle without pushing it.Her mother did the wrong way, she cannot learn new things since she is used for the old procedure, she stated there is nothing wrong with the pen needle, she did not have product information to provide.".

• Brand Name: UNSPECIFIED BD¿ PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9534204
• MDR Text Key: 178022198
• Report Number: 2243072-2019-02912
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/16/2019

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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