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

Catalog Number UNKNOWN

Device Problem Failure to Deliver (2338)

Patient Problems Hyperglycemia (1905); Skin Inflammation/ Irritation (4545)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported that the unspecified bd ultrafine nano pen needle experienced a case of being unable to deliver insulin, and a case of not functioning.The following information was provided by the initial reporter: after starting insulin therapy, his pen got locked up, he was not able to get all medication out of it.It stopped working.

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 birth: only the patient's age was provided, therefore a default date of birth has been listed.Device expiration date: unknown.Date of event: unknown.The date received by manufacturer has been used for this field.Device manufacture date: unknown.

Manufacturer Narrative

Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.

Event Description

It was reported that the unspecified bd ultrafine nano pen needle experienced a case of being unable to deliver insulin, and a case of not functioning.The following information was provided by the initial reporter: after starting insulin therapy, his pen got locked up, he was not able to get all medication out of it.It stopped working.

• Brand Name: UNSPECIFIED BD ULTRAFINE NANO 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13620824
• MDR Text Key: 287597368
• Report Number: 2243072-2022-00291
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 03/03/2022
• Supplement Dates FDA Received: 03/20/2022
• 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 Age: 64 YR
• Patient Sex: Male