MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PRO PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320559

Device Problem Defective Device (2588)

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

Event Date 12/08/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.

Event Description

It was reported that the bd micro-fine¿+ pro pen needle outer cover kept spinning when the user attached a pen needle to the pen.The following information was provided by the initial reporter, translated from japanese to english: the customer's report is that the outer cover kept spinning when the user attached a pen needle to the pen.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-jan-2023.H6: investigation summary: two open 32g x 4mm pen needle samples and two photos were returned from an unknown lot.No., cat.No.320559.A functionality test was carried out on the returned samples and a loose hub in cover was observed on both samples.No dhr review can be carried out as lot number is unknown.This issue was most likely caused by an interference fit between the hub and the cover.H3 other text : see h10.

Event Description

It was reported that the bd micro-fine¿+ pro pen needle outer cover kept spinning when the user attached a pen needle to the pen.The following information was provided by the initial reporter, translated from japanese to english: the customer's report is that the outer cover kept spinning when the user attached a pen needle to the pen.

• Brand Name: BD MICRO-FINE¿+ PRO 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: 16065523
• MDR Text Key: 308403774
• Report Number: 9616656-2022-01427
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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