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

Model Number 320550

Device Problems Misconnection (1399); Failure to Disconnect (2541)

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

Event Date 08/31/2022

Event Type  malfunction  

Event Description

It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate and attach to the pen prior to use.Additionally, the needle was also unable to be detached after the injection.The following information was provided by the initial reporter: "consumer stated, non patient end is not attaching to insulin pen prior to injection stated, some pen needles, once they are attached, she cannot remove after injection".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter e-mail: unknown.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 and attach to the pen prior to use.Additionally, the needle was also unable to be detached after the injection.The following information was provided by the initial reporter: "consumer stated, non patient end is not attaching to insulin pen prior to injection stated, some pen needles, once they are attached, she cannot remove after injection".

Manufacturer Narrative

H6: investigation summary customer returned (31) unopened 32gx4mm bd pen needles from lot# 1138232.The customer stated that the non-patient end (npe) is not attaching to an insulin pen, and, once attached, the pen needle cannot be removed.All 31 samples were opened and tested for attachment and detachment to and from a test pen injector: all 31 pen needles were able to thread onto and off the test pen injector properly.No evidence of manufacturing defect was observed.The alleged issues could not be confirmed based on the samples returned for investigation.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• 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: 15481168
• MDR Text Key: 306020790
• Report Number: 9616656-2022-01041
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: (01)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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2022
• 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: 1138232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2021
• 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