MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON 22MM HTD NIV CIRC KIT; RESPIRATORY GAS HUMIDIFIER

Catalog Number 870-98KIT

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are incomplete at the time of this report.

Event Description

The customer alleges that there was a disconnection between the tubing and the port.No patient harm reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the pressure port stem was completely broken off the pressure port valve.The reported complaint was confirmed based upon the sample received.The returned circuit was confirmed to have a broken pressure port stem.The defect was discovered after being in use for some undetermined amount of time.All circuits are 100% inspected for damaged circuit components at the time of manufacturing; therefore, 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 there was a disconnection between the tubing and the port.No patient harm reported.

• Brand Name: HUDSON 22MM HTD NIV CIRC KIT
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• 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: 5939084
• MDR Text Key: 54300454
• Report Number: 3004365956-2016-00347
• Device Sequence Number: 1
• Product Code: BTT
• 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: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 08/29/2016

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: 870-98KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2016
• Initial Date FDA Received: 09/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/06/2016
• 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