MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-VENT PEDIATRIC; CONDENSER, HEAT AND MOISTURE

Catalog Number 11012

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer at the time of this report.The investigation of this complaint is still in progress.

Event Description

Customer complaint alleges "the device fell apart in the nurses hands when she tried to attach it to the tubing".Alleged event reported as during use.It was reported there was no medical intervention necessary.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The sample was returned for evaluation.A visual exam was performed and it was observed that the product was detached.It was reported that the product detached during use.Improper assembly could be the reason that the product detaches.In the current manufacturing procedure, 100% leak testing during the assembly process is conducted, along with a 100% visual inspection at the packing area; therefore, any defects would be detected prior to release.Ten pieces of the same catalog number were taken at the manufacturing facility and inspected.No visual defects were found and all ten passed leak testing.Although the product was found to be detached, a root cause for the issue could not be established.(b)(4).

Event Description

Customer complaint alleges "the device fell apart in the nurses hands when she tried to attach it to the tubing".Alleged event reported as during use.It was reported there was no medical intervention necessary.Patient condition reported as "fine".

• Brand Name: HUDSON HUMID-VENT PEDIATRIC
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia NC
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6526508
• MDR Text Key: 73906995
• Report Number: 8040412-2017-00088
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/12/2017

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 Expiration Date: 10/31/2021
• Device Catalogue Number: 11012
• Device Lot Number: 201648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1