MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD NANO¿ 4MM X 32G 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number UNKNOWN

Device Problem Misconnection (1399)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that 2 - 3 unspecified bd nano¿ 4mm x 32g 2nd gen pen needles were difficult to operate during use.The following information was provided by the initial reporter: "im diabetic and i have ti use the bd nano 2nd gen pen needles for my 2 insulin pens., these pen needles are 4mmx32g 100count each box.I have purchased 3 boxes and this 3rd box im having trouble with.I have to do injections 3x;s a day, like every other day i come across 2 sometimes 3 needles that do not work.Its like a manufacture defect i guess.".

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.Initial reporter phone#: unknown.The customer's address is unknown.(b)(4) 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.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary: unable to perform complaint lot history check due to an unknown lot number for difficult/unable to operate.The occurrence is unknown since the lot number is unknown.This will be considered the 1st related complaint for guidance on the investigation.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.Due to the batch being unknown, no dhr review can be completed.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 root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that 2 - 3 unspecified bd nano¿ 4mm x 32g 2nd gen pen needles were difficult to operate during use.The following information was provided by the initial reporter: "im diabetic and i have ti use the bd nano 2nd gen pen needles for my 2 insulin pens., these pen needles are 4mmx32g 100count each box.I have purchased 3 boxes and this 3rd box im having trouble with.I have to do injections 3x;s a day, like every other day i come across 2 sometimes 3 needles that do not work.Its like a manufacture defect i guess.".

• Brand Name: UNSPECIFIED BD NANO¿ 4MM X 32G 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15476930
• MDR Text Key: 301813386
• Report Number: 2243072-2022-01600
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2022

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
• Initial Date Manufacturer Received: 08/30/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/27/2022
• 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