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

Catalog Number 320129

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that one bd micro fine plus¿ pen injector needle has been found experiencing inability for the cap to detach.The following has been provided by the initial reporter: the pen needle wouldn't detach.The customer complained it was difficult to remove the pen needle because the clear outer case was loose.

Manufacturer Narrative

H.6.Investigation: no samples or photos were returned for analysis.No dhr review can be carried out as lot number is unknown.Complaint could not be confirmed and root cause is undetermined.H3 other text : see h.10.

Event Description

It has been reported that one bd micro fine plus¿ pen injector needle has been found experiencing inability for the cap to detach.The following has been provided by the initial reporter: the pen needle wouldn't detach.The customer complained it was difficult to remove the pen needle because the clear outer case was loose.

• Brand Name: BD MICRO FINE PLUS¿ PEN INJECTOR NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9521726
• MDR Text Key: 194649278
• Report Number: 9616656-2019-01271
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320129
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other