MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD PEN NEEDLE

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Underdose (2542); Missed Dose (2561)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog or a 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.The customer's address is unknown:  (b)(6), usa has been used as a default.  a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a needle clog occurred during use with a unspecified bd pen needle.The following information was provided by the initial reporter, "hello, i have been using your products for decades now and have been pleased with the quality.I purchased a box of your ultra fine pen needles 4mm x 32g nano recently and have been experiencing high blood sugars.I realized today that the needle is not penetrating through the tip of the insulin, so i believe i am injecting yet no insulin is being injected into me.I was at work and did not have another needle to use and understood that what insulin i had thought i had injected before breakfast had not gone into me and since it was the same needle i was trying to use at lunch i had gone all day without insulin.I have used about half of the box and realize that all the high sugar readings i have been experiencing are because the needles are faulty.I wanted you to be aware of this because for those of us who are dependent on insulin injections we rely on your products to work.I trust that you will take the necessary steps in checking the machinery and quality of the finished products so your customers are safe.".

Event Description

It was reported that a needle clog occurred during use with a unspecified bd pen needle.The following information was provided by the initial reporter, "hello, i have been using your products for decades now and have been pleased with the quality.I purchased a box of your ultra fine pen needles 4mm x 32g nano recently and have been experiencing high blood sugars.I realized today that the needle is not penetrating through the tip of the insulin, so i believe i am injecting yet no insulin is being injected into me.I was at work and did not have another needle to use and understood that what insulin i had thought i had injected before breakfast had not gone into me and since it was the same needle i was trying to use at lunch i had gone all day without insulin.I have used about half of the box and realize that all the high sugar readings i have been experiencing are because the needles are faulty.I wanted you to be aware of this because for those of us who are dependent on insulin injections we rely on your products to work.I trust that you will take the necessary steps in checking the machinery and quality of the finished products so your customers are safe.".

Manufacturer Narrative

Level a investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: unable to perform complaint lot history check due to an unknown lot number for needle clog & glucose levels.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 needle clog & glucose levels.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 root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9083591
• MDR Text Key: 163145514
• Report Number: 2243072-2019-02058
• 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,other
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/18/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other