MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER,HAND-HELD,W/6" CORR TUBING; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1724

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74g1700840 that belong to catalog number 1724 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The device has been received for evaluation, however the evaluation is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the device investigation.

Event Description

Customer complaint states the doctor "found the cup leaking when the medicine was injected into the cup prior to use on patient.Replaced new one to complete the treatment.Patient is fine.".

Event Description

Customer complaint states the doctor "found the cup leaking when the medicine was injected into the cup prior to use on patient.Replaced new one to complete the treatment.Patient is fine.".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was a defect with the mold of the cap of the nebulizer.Regarding this issue a non-conformance was issued in order to further investigate and document all corrective action.

• Brand Name: HUDSON NEBULIZER,HAND-HELD,W/6" CORR TUBING
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8399428
• MDR Text Key: 138104701
• Report Number: 3004365956-2019-00061
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K760489
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

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: Health Professional
• Device Catalogue Number: 1724
• Device Lot Number: 74G1700840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.