MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM X 31G (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 320109

Device Problem Misconnection (1399)

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

Event Date 05/31/2022

Event Type  malfunction  

Event Description

It was reported that while using a bd ultra-fine¿ short pen needles 8mm x 31g (100 count), the device was difficult operate and not working properly.The following information was provided by the initial reporter: consumer reported that the needle will not attach to the insulin pen, stated that the needle spins but does not tighten.

Manufacturer Narrative

The date received by manufacturer has been used for this field.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.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.

• Brand Name: BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM X 31G (100 COUNT)
• 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: 14844776
• MDR Text Key: 297540537
• Report Number: 9616656-2022-00674
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903201099
• UDI-Public: 00382903201099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162516
• 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: 06/01/2022

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: 320109
• Device Catalogue Number: 320109
• Device Lot Number: 1272201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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