MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this report.A device history record review could not be conducted since the lot number was not provided.The device sample is needed for a proper and thorough investigation.Customer complaint cannot be confirmed at this time.Root cause cannot be determined.Corrective actions cannot be established.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint reported "soon after started oxygen administration, the alarm of "spo2 reduction" occurred and the patient expressed breathing trouble.Then, the nurse checked to find the adaptor leaking.(continued) therefore, the nurse replaced the leaking adaptor with a new one.After replacement, spo2 recovery was confirmed, also the patient's condition soon recovered, and no serious problem occurred.

Event Description

Customer complaint reported "soon after started oxygen administration, the alarm of "spo2 reduction" occurred and the patient expressed breathing trouble.Then, the nurse checked to find the adaptor leaking.(continued) therefore, the nurse replaced the leaking adaptor with a new one.After replacement, spo2 recovery was confirmed, also the patient's condition soon recovered, and no serious problem occurred.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.During the visual inspection it was observed that the received sample is incomplete since the puncture pin and protective cap are missing.It was also noticed that there was a cut in the tubing.No other issues were found.Functional testing could not be performed due to the cut in the tubing.The complaint could not be confirmed.The received sample was found with a cut on the tubing supply and missing components , thus, there is not sufficient evidence to assure this issue was originated during the manufacturing process.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8265068
• MDR Text Key: 133864781
• Report Number: 3004365956-2019-00013
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• 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: 01/11/2019

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: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 01/21/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 03/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOW METER.; FLOW METER.