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

Model Number 320550

Device Problem Misconnection (1399)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd nano¿ 2nd gen pen needle was difficult to operate.The following information was provided by the initial reporter: consumer reported that the needle will not attach to the insulin pen.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-nov-2022.H6: investigation summary: customer returned a total of (b)(4) used 4mm, 32 gauge nano pro pen needles.The lot number could not be confirmed as no teardrop labels were returned.The pen needles were visually inspected prior to testing.2 of the pen needles were found to have bent needles on the non-patient side of the hub¿s needle cannula.This damage would prevent the pen needle from properly attaching to the insulin pen.Based on the damage present, the needles bending may have occurred accidentally while the user was preparing the pen needle for use, potentially if the pen was not properly aligned with the cannula.The remaining samples were attached to a test pen filled with saline.Saline was pushed through the system and out the distal tip of the remaining pen needle.No issues were found with the remaining pen needle.A complaint lot history check was performed on lot # 2026081 for does not attach as intended.Based on the samples received, embecta found that 2 pen needles had become bent on the non-patient side.This damage could be the result of attempting to attach the pen needles at the wrong angle, resulting in the cannulas bending and preventing the pen needles from attaching to the pen.The root cause of the needles bending appears to be accidental damage from stresses caused by the user during routine use.H3 other text : see h10.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate.The following information was provided by the initial reporter: consumer reported that the needle will not attach to the insulin pen.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15752947
• MDR Text Key: 307697389
• Report Number: 9616656-2022-01207
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• 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: 01/11/2023

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 Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 2026081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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