MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND UNKNOWN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number UNKNOWN

Device Problem Misconnection (1399)

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

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not available.

Event Description

Consumer reported that non patient end is not attaching correctly.Stated, she threw away a lot of pen needles that she found with that issue stated, does not re-use lot: unknown catalog: 320574 date of event: unknown samples: no cl.

Manufacturer Narrative

Additional information was added to: g6, h2, h3, h6, h10.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.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: UNKNOWN
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18663917
• MDR Text Key: 334849156
• Report Number: 9616656-2024-05069
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1