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 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Customer complaint alleges "constantly losing 100cc's of tidal volume which could cause the vent to alarm.They swap it out and it usually fixes the issue temporarily." no patient harm reported.

Event Description

Customer complaint alleges "constantly losing 100cc's of tidal volume which could cause the vent to alarm.They swap it out and it usually fixes the issue temporarily." no patient harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and the sample was assembled into a teleflex respiratory circuit.Leak testing was performed the results were satisfactory.Based on the investigation performed, the reported complaint of leaking 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: 9872145
• MDR Text Key: 190140460
• Report Number: 3004365956-2020-00085
• 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: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Date Manufacturer Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.