MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 780-15 CIRCUIT W/ COLUMN; HUMIDIFIER NEBULIZER KIT

Catalog Number 780-15KIT

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Conclusion: the complaint was confirmed, but the root cause could not be identified.A video was received as part of the complaint information.The video shows a circuit under water and it can be observed bubbles between the jar & water trap that appears to have a leak between both components.The device history record of batch number 74a1602675 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Customer complaint is confirmed based on video provided that shows a circuit that appears to have a leak between the jar and the water trap.However, physical sample is necessary to conduct a proper investigation and determine the source of defect reported.If device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that the infant circuit failed the pre-test.The customer alleges that there is a leak at the location where the cup screws into the housing (trap).No patient injury reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no tube melting or charring was detected.The entire circuit was leak tested.In order to thoroughly capture all leaks, if any, both limbs of the circuit were submerged under a bath of plain tap water to see if any bubbles could be detected from leaks.Immediately leaks were detected at both rain trap cups, one on the inspiratory limb, the other on the expiratory limb.The leaks were coming from where the collection cup attaches by plastic threads to the rain trap base.These leaks were so profuse an acceptable rate of leak volume was unobtainable.Based on the investigation performed, the reported complaint was confirmed.The returned circuit was confirmed to leak from the expiratory and inspiratory limb water traps.A dhr review was performed on the product with no evidence to suggest a manufacturing related cause.All circuits are 100% inspected for leaks at the time of manufacturing; therefore, any defects would be detected prior to release.This defect was discovered during preliminary testing (prior to use), sst testing on a ventilator.Other remarks: based upon the time of discovery and the damage observed on the returned sample, it was determined that operational context caused or contributed to this event.

Event Description

The customer alleges that the infant circuit failed the pre-test.The customer alleges that there is a leak at the location where the cup screws into the housing (trap).No patient injury reported.

• Brand Name: HUDSON 780-15 CIRCUIT W/ COLUMN
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6076891
• MDR Text Key: 59083905
• Report Number: 3004365956-2016-00411
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/07/2020
• Device Catalogue Number: 780-15KIT
• Device Lot Number: 74A1602675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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
• Treatment: SERVO-I VENTILATOR