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

Catalog Number 320559

Device Problem Misconnection (1399)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.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.Device manufacture date: unknown.

Event Description

It was reported that the bd micro-fine¿+ pro pen needle was unable to attach to the pen during use.The following information was provided by the initial reporter, translated from japanese: "the customer's report is that the pen needle could not be attached to the pen".

Manufacturer Narrative

No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.H3 other text : see h10.

Event Description

It was reported that the bd micro-fine¿+ pro pen needle was unable to attach to the pen during use.The following information was provided by the initial reporter, translated from japanese: "the customer's report is that the pen needle could not be attached 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: 15452488
• MDR Text Key: 305706563
• Report Number: 9616656-2022-01012
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205592
• UDI-Public: (01)00382903205592
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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