MAUDE Adverse Event Report: CROSSTEX BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR

Model Number ZWWIBK

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Difficult to Remove (1528)

Patient Problems Aspiration/Inhalation (1725); Foreign Body In Patient (2687)

Event Date 07/09/2015

Event Type  Injury  

Event Description

The facility reported a tip that fell off of a saliva ejector during a dental procedure.The patient aspirated the tip and it lodged in the patient's lung.Surgery was required to remove the tip.

Manufacturer Narrative

The facility reported a tip that fell off of a saliva ejector during a dental procedure.The patient aspirated the tip and it lodged in the patient's lung.Surgery was required to remove the tip.Crosstex qa and manufacturing evaluations are underway and crosstex is still in close communication with the distributor.There are no other adverse events related to this product.Patient condition is unknown at this time.This complaint will continue to be monitored and maintained by the crosstex complaint handling system.

Manufacturer Narrative

The facility reported a tip that fell off of a saliva ejector during a dental procedure.The patient aspirated the tip and it lodged in the patient's lung.Surgery was required to remove the tip.Crosstex qa and manufacturing evaluations are underway and crosstex is still in close communication with the distributor.There are no other adverse events related to this product.Patient condition is unknown at this time.This complaint will continue to be monitored and maintained by the crosstex complaint handling system.A voluntary recall of the problem device lot was initiated on 17 july 2015 by (b)(4).

Event Description

The facility reported a tip that fell off of a saliva ejector during a dental procedure.The patient aspirated the tip and it lodged in the patient's lung.Surgery was required to remove the tip.

• Brand Name: BURKHART PRIVATE LABEL ADVANTAGE SALIVA EJECTOR
• Type of Device: SALIVA EJECTOR
• Manufacturer (Section D): CROSSTEX; 10 ranick rd; hauppauge NY 11788
• Manufacturer (Section G): CROSSTEX; 10 ranick rd; hauppauge NY 11788
• Manufacturer Contact: kristin bergeson ; 10 ranick rd; hauppage, NY 11788
• MDR Report Key: 4907329
• MDR Text Key: 18994676
• Report Number: 2433773-2015-00001
• Device Sequence Number: 1
• Product Code: DYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor,distributor,health p
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Model Number: ZWWIBK
• Device Lot Number: 04/10/151
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention