MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV

Catalog Number 1734

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product or a picture was not provided.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.The customer complaint cannot be confirmed based only on the information provided.To perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However material from current inventory at the manufacturing facility was functionally inspected and no issues were detected that could lead to the reported issue.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer reports that the tubing on the nebulizer pops off the flowmeter when set a 6lpm.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the tubing was kinked and there was a white residue found inside of the jar, cap, and jet.A microscopic inspection revealed that a green particulate was found at the top opening and bottom opening of the orifice of the jet.A functional inspection was performed to determine if the nebulizer was misting.5cc of water was added to the returned nebulizer unit and the tubing was connected to an air flowmeter and the pressure was increased to 8 lpm.A mist was not produced from the chamber of the nebulizer.Also, during functional testing, the tubing popped off the jet.The reported complaint that the tubing pops off during use was confirmed through the functional inspection of the returned sample.Also, during the functional inspection the nebulizer did not produce mist and it bubbled.The microscopic inspection revealed that there was a green particulate found at the top opening and bottom opening of the orifice of the jet.A dhr review could not be conducted since the lot number was not provided.A capa has been initiated to further investigate this complaint issue.

Event Description

The customer reports that the tubing on the nebulizer pops off the flowmeter when set a 6lpm.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).The sample was returned to the manufacturer for further investigation.The manufacturer reports that no issues could be found with the sample during functional testing.The device functioned as intended.Evaluation codes have been updated to reflect this investigation.

Event Description

The customer reports that the tubing on the nebulizer pops off the flowmeter when set a 6lpm.No patient injury or harm reported.

• Brand Name: HUDSON UP-DRAFT II OPTI-NEB NEBULIZER W/RESERV
• Type of Device: NEBULIZER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6476970
• MDR Text Key: 72345586
• Report Number: 3004365956-2017-00137
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1734
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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