MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 1882

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "(b)(6) 2019, (b)(6) hospital of (b)(6), doctor found the tubing leakage after the nebulizer connected with oxygen prior to use on patient.".

Event Description

It was reported that "(b)(6) 2019, traditional chinese medicine hospital of guangdong province, doctor found the tubing leakage after the nebulizer connected with oxgen prior to use on patient.".

Manufacturer Narrative

(b)(4).The customer returned tubing from catalog number 1882 micro mist nebulizer w/tee, tubing and mouthpiece for analysis, batch 74f1801841.During the visual inspections, it was observed that the customer had marked/circled the defective area on the tubing with a black marker.No other issues were observed.Functional testing was performed and the sample failed the leak test since leakage was observed on the connector and tubing assembly.A device history record review was performed and no relevant findings were identified.The dhr shows that the product was assembled and inspected according to specifications.Based on the investigation performed, the reported complaint was confirmed.A non-conformance was opened to address this issue.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8807842
• MDR Text Key: 151605663
• Report Number: 3004365956-2019-00201
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• 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: 07/15/2019

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: 1882
• Device Lot Number: 74F1801841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1