MAUDE Adverse Event Report: INTEGRA YORK, PA INC. VANTG METAL EAR SYRINGE 4; M11 - ENT

Catalog Number V919-385

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports via medwatch # (b)(4) that ear wax was being removed by ent physician when the patient was injured.The physician was irrigating the patient's ear when the end of the plunger flew off and struck the inner ear that caused bleeding, but did not damage the ear drum.Patient was treated in the moment with direct pressure to the site of bleeding and offered ear drops to moisten ear wax.Patient was seen two weeks later and the ear wax was removed manually.On 12/1/2015 customer reports physician thinks the device threads may have been damaged from use and so the part came off.

Manufacturer Narrative

1/18/16 integra investigation completed.Manufacturing date unknown.Method: failure analysis, device history evaluation results: failure analysis - failure analysis cannot be performed based on the lack of information provided by the customer.The ear syringe was not returned for further evaluation.Device history evaluation - dhr review was completed with all history available.Nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report/nonconforming material report history.Variance authorization / deviation history: none.Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history.Corrective action preventive action history: there are no applicable corrective action preventive action history.Health hazard evaluation history: none.Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation.The ear syringe was not returned for further evaluation.

• Brand Name: VANTG METAL EAR SYRINGE 4
• Type of Device: M11 - ENT
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA 17402
• Manufacturer (Section G): INTEGRA YORK, PA INC.; 589 davies drive; york PA 17402
• Manufacturer Contact: sandra lee ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5320828
• MDR Text Key: 34242866
• Report Number: 2523190-2015-00136
• Device Sequence Number: 1
• Product Code: KCP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: V919-385
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR