TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; NEBULIZER (DIRECT PATIENT INTE
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|