MAUDE Adverse Event Report: BECTON DICKINSON BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320559

Device Problem Material Twisted/Bent (2981)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/15/2023

Event Type  Injury  

Event Description

It ws reported that the bd nano¿ 2nd gen pen needle stuck the health care provider.The following was translated from japanese to english: this report is about needle bent and needle stick.A safety needle is usually used, but in this rare case it was removed by a hcp.The needle pe (ventral side) was bent and needle stick occurred.(hcp got needlestick.).

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.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.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

This report is about needle bent and needle stick.A safety needle is usually used, but in this rare case it was removed by a hcp.The needle pe (ventral side) was bent and needle stick occurred.(hcp got needlestick.).

• Brand Name: BD NANO¿ 2ND GEN 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17840864
• MDR Text Key: 324558391
• Report Number: 2243072-2023-01751
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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: 320559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: No
• 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