MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 32G 4MM PRO 100 BOX 1200 US; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 320550

Device Problem Misconnection (1399)

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

Event Type  malfunction  

Event Description

Consumer reported that the needles will not attach, stated that the threading is not there.Lot #: 3108819.Catalog #: 320550.Date of event: unknown.Samples: available - sending mail kit.

Manufacturer Narrative

Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

• Brand Name: PEN NDL 32G 4MM PRO 100 BOX 1200 US
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18684988
• MDR Text Key: 336411010
• Report Number: 9616656-2024-05075
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• 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: 05/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 320550
• Device Lot Number: 3108819
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• Patient Sequence Number: 1