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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems Neuropathy (1983); Underdose (2542)

Event Date 10/13/2020

Event Type  Injury  

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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the unspecified bd¿ pen needle broke and resulted in the patient being underdosed, which lead to neuropathy.Product: needles of insulin pens problem: needles are too ¿weak¿ comment from: xxxxx.Comment: the needles for insulin pens are so weak i break them during injection.I can't tell if i got my full dose most of the time.This has lead to neuropathy.I just use a regular syringe to extract the proper dosage now.Please make the needles stronger so other people don't get neuropathy.It really really sucks.

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.See h.10.

Event Description

It was reported that the unspecified bd¿ pen needle broke and resulted in the patient being underdosed, which lead to neuropathy.The following information was provided by the initial reporter: this email to report the below complaint on a bd youtube video posted one month ago link: https://www.Youtube.Com/watch?v=i4na2xgqtze product: needles of insulin pens problem: needles are too ¿weak¿ comment from: xxxxx comment: the needles for insulin pens are so weak i break them during injection.I can't tell if i got my full dose most of the time.This has lead to neuropathy.I just use a regular syringe to extract the proper dosage now.Please make the needles stronger so other people don't get neuropathy.It really really sucks.

• 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
• MDR Report Key: 10782749
• MDR Text Key: 214614186
• Report Number: 2243072-2020-01778
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• 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: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other