MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRACH-VENT+STERILE; CONDENSER, HEAT AND MOISTURE

Catalog Number 41311U

Device Problems Partial Blockage (1065); Detachment Of Device Component (1104)

Patient Problems Bradycardia (1751); No Consequences Or Impact To Patient (2199); Low Oxygen Saturation (2477)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer contacted for clarification of the term "nose".Customer states "nose" means artificial nose (device).Photo submitted appears to show a portion of a device has fallen into the device itself.Reported event of low saturation and bradycardia was transient as customer reported the patient meanwhile is fine and breathing spontaneously.The physical device sample has not been returned to the manufacturer at the time of this report.The investigation into this complaint is still in progress.

Event Description

Original customer complaint alleges that "the cap of the safety port (overpressure valve) has released and fallen into the nose." alleged event reported as occurring during use.Additional information obtained reported "the cap of the vent with the slotted membrane has loosened and fell into the device.Due to this the vent became blocked and the patient had a saturation of 30/31, heart rate decreased to 40.Meanwhile patient is fine and breathing spontaneously.No further patient harm is known to date.".

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was extra silicone found in the device.Based on this visual exam, the complaint has been confirmed.A capa was opened to address this issue.

Event Description

Original customer complaint alleges that "the cap of the safety port (overpressure valve) has released and fallen into the nose." alleged event reported as occurring during use.Additional information obtained reported "the cap of the vent with the slotted membrane has loosened and fell into the device.Due to this the vent became blocked and the patient had a saturation of 30/31, heart rate decreased to 40.Meanwhile patient is fine and breathing spontaneously.No further patient harm is known to date.".

• Brand Name: RUSCH TRACH-VENT+STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• 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: 6573241
• MDR Text Key: 75418044
• Report Number: 8040412-2017-00108
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 41311U
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/21/2017
• 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