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

Model Number 320550

Device Problem Misconnection (1399)

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

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Investigation summary: a complaint history check was performed and this is the 2nd.Related complaint for does not attach as intended on lot # 1075773.A review of risk management document (b)(4), revision 11, indicates that the potential risk of this specific reported incident (nano pro pen needle: does not attach as intended) was captured and addressed.Investigation summary: customer returned (13) open 32gx4mm bd pen needles without tear drop labels or inner shields attached.The customer reported that the non-patient end (npe) would not attach to the insulin pen prior to injection.All 13 samples were examined, and it was observed that 11 pen needles featured a bent npe cannula and 2 featured a broken npe cannula.The bent and broken npe cannulas would prevent the pen needles from properly attaching to a pen injector.Since all 13 samples were returned after use, the probable cause of the bent and broken npe cannulas is user error when attaching the pen needles to a pen injector.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Based on the samples and/or photo(s) received the investigation concluded: confirmed: embecta was able to duplicate or confirm the customer¿s indicated failure (npe cannula bent, npe cannula broken) complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The root cause for this issue is user related.The npe cannulas were bent or broken by the user when handling the pen needles.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported while using bd nano¿ 2nd gen pen needles that the non patient end would not attach to insulin pen prior to injection on 20 pen needles.The following information was provided by the initial reporter: consumer reported non patient end would not attach to insulin pen prior to injection.20 pen needles affected.

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLES
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 14800368
• MDR Text Key: 296059905
• Report Number: 9616656-2022-00664
• 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
• Report Date: 05/27/2022

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 Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 1075773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• 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