MAUDE Adverse Event Report: INTEGRA YORK, PA INC. SCHUKNECHT SUC TUBE 24GA; JARIT

Catalog Number X20697

Device Problem Break (1069)

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

Event Type  malfunction  

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based on the reported information.

Event Description

Customer initially reports schuknecht suction tube 24ga broke at hub during use in surgery.On (b)(6) 2016, customer reports device broke while suctioning the nasal cavity.No harm done, no further information available.

Manufacturer Narrative

On 8/31/16 integra investigation completed.Manufacture date two suction tubes: august 2015 and march of 2016.Method: failure analysis, device history evaluation.Results: failure analysis - two suction tubes returned in used condition, showing one with purple tape marking and another with yellow and orange tape marking showing wear, and broken shafts.While performing the visual inspection of the instrument; it is noticed where the shaft area is broken.Without knowing how the instrument was handled and how much pressure was used during use, the cause of the complaint is undetermined.The complaint report is confirmed.Device history evaluation - nonconforming product report / nonconforming material report history: none.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/corrections: none.Health hazard evaluation history: none.Conclusion: the root cause has not been identified as a workmanship or material deficiency.

• Brand Name: SCHUKNECHT SUC TUBE 24GA
• Type of Device: JARIT
• 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: 5917132
• MDR Text Key: 53623502
• Report Number: 2523190-2016-00132
• Device Sequence Number: 1
• Product Code: JZF
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: X20697
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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