MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,PRESSURE LINE; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 1642

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the adaptor leaked during patient use.It was reported adaptors "fail and loose pressure on our ventilators".No patient harm was reported.No medical intervention required.

Event Description

Customer reported the adaptor leaked during patient use.It was reported adaptors "fail and loose pressure on our ventilators".No patient harm was reported.No medical intervention required.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the sample was assembled into a teleflex respiratory circuit and a leak test was performed.No issues were encountered during testing.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The unit functioned as intended.

• Brand Name: HUDSON ADAPTOR,PRESSURE LINE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9763320
• MDR Text Key: 193327303
• Report Number: 3004365956-2020-00053
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

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: No Information
• Device Catalogue Number: 1642
• Device Lot Number: 74E1903398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HIGH-PRESSURE VENTILATOR SETTING; HIGH-PRESSURE VENTILATOR SETTING