MAUDE Adverse Event Report: TELEFLEX MEDICAL MAD NASAL WITH 3 ML SYRINGE; NEBULIZER, MEDICINAL, NON-VENT

Model Number IPN915303

Device Problem Component Missing (2306)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that "nasal plug missing on the device in an unopened packaging".The issue was identified in the warehouse.There was no patient involvement.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn # (b)(4).The reported complaint of "additional/missing component - missing" was confirmed based upon the sample received.Visual examination of the returned device revealed that only the syringe was returned in the packaging.The packaging was confirmed to be sealed properly.A device history record review was performed on the device with no evidence to suggest a manufacturing related root cause.The mad device was missing.An investigation within teleflex has been initiated to further investigate this complaint issue.

Event Description

It was reported that "nasal plug missing on the device in an unopened packaging".The issue was identified in the warehouse.There was no patient involvement.

• Brand Name: MAD NASAL WITH 3 ML SYRINGE
• Type of Device: NEBULIZER, MEDICINAL, NON-VENT
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18719695
• MDR Text Key: 335555804
• Report Number: 3003898360-2024-00228
• Device Sequence Number: 1
• Product Code: CCQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915303
• Device Catalogue Number: MAD100
• Device Lot Number: 73H2301162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2023
• 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