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).

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.Signs of use were observed since a disinfection tag is present and the sample was not received in its original package.No other issues were found.Functional testing was performed and the sample was assembled into a teleflex respiratory circuit and a functional leak test was performed.No issues were encountered.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

• Brand Name: HUDSON ADAPTOR,PRESSURE LINE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9872174
• MDR Text Key: 190140324
• Report Number: 3004365956-2020-00086
• 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

• 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: 03/19/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/02/2020
• Supplement Dates FDA Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.