MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1613

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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

Complaint reported as "circuits would not pass leak test on pre use check.".There was no patient involvement.

Manufacturer Narrative

(b)(4).The sample was not returned; however, the customer provided a photo for evaluation.Based on the review of the photo, it was observed there was a cut on the tubing.It cannot be determined that such cut was performed in the manufacturing process.Based on this, the customer complaint cannot be confirmed based only on the photo provided.To perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

Complaint reported as "circuits would not pass leak test on pre use check.".There was no patient involvement.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 9106231
• MDR Text Key: 191743034
• Report Number: 3004365956-2019-00256
• Device Sequence Number: 1
• Product Code: CAI
• 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: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1613
• Device Lot Number: 74E1903143
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.