MAUDE Adverse Event Report: TELEFLEX MEDICAL HUSDON NEB ADAPTOR 028, NON-STERILE, SHELFPAK; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-28

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "when installing the product, it does not produce fog".The issue was detected prior to patient use.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was received for evaluation.A visual exam was performed and no defects were observed.The sample was then functionally tested and no issues were encountered.The device history record of batch number 74f1800669 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed the complaint could not be confirmed.There are no issues found with the returned device.The unit functioned as intended.

Event Description

The complaint is reported as: "when installing the product, it does not produce fog".The issue was detected prior to patient use.No patient injury reported.

• Brand Name: HUSDON NEB ADAPTOR 028, NON-STERILE, SHELFPAK
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8583747
• MDR Text Key: 144182332
• Report Number: 3004365956-2019-00105
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

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: No Information
• Device Catalogue Number: 031-28
• Device Lot Number: 74F1800669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 05/06/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1