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

Catalog Number 320559

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Easy Bruising (4558)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd micro-fine¿ pro pen needle was difficult to remove from the pen during use.The following information was provided by the initial reporter, translated from japanese: "this report is about patient internal bleeding and cuts.The patient has been using product since may for insulin infusion and occasionally has internal bleeding.The patient finds it more difficult to remove the needle than to stick it in.The patient may have a wound that looks like a small horizontal cut.The patient want to know how to inject smoothly.".

Manufacturer Narrative

H6: investigation summary 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.

Event Description

It was reported that the bd micro-fine¿ pro pen needle was difficult to remove from the pen during use.The following information was provided by the initial reporter, translated from japanese: "this report is about patient internal bleeding and cuts.The patient has been using product since may for insulin infusion and occasionally has internal bleeding.The patient finds it more difficult to remove the needle than to stick it in.The patient may have a wound that looks like a small horizontal cut.The patient want to know how to inject smoothly.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17708945
• MDR Text Key: 322947147
• Report Number: 9616656-2023-00983
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• 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