MAUDE Adverse Event Report: COOK INC COOK PNEUMOTHORAX SET

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

On (b)(6) 2016: cook pneumothorax set was placed in the patient, and there was no problem.(no information of patient anatomy or access route, however the user used the device as usual.).On (b)(6) 2016: it was noticed that the catheter was separated from the hub.The catheter was replaced with another catheter of the same product.No adverse effect to the patient reported.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of complaint history, documentation, drawing, manufacturing instructions, quality control, specifications and a visual inspection of the returned device was conducted during the investigation.The visual examination reported the hub was separated from the catheter.A review of the flare noted scratches and damage.A review of the cap noted a thin line of catheter material still remains around the inner diameter of the cap.The suspected lot number from the customer is #629333, the manufacturing record for this suspected lot was reviewed, and nothing of note was observed.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.However, it is feasible to suggest that twisting and pulling on the catheter could cause the flared portion to be pulled and removed from the hub.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment (qera) no further action is required.

Event Description

On (b)(6) 2016: cook pneumothorax set was placed in the patient, and there was no problem.(no information of patient anatomy or access route, however the user used the device as usual.) on (b)(6) 2016: it was noticed that the catheter was separated from the hub.The catheter was replaced with another catheter of the same product.No adverse effect to the patient reported.

• Brand Name: COOK PNEUMOTHORAX SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5673077
• MDR Text Key: 46189621
• Report Number: 1820334-2016-00415
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPT-200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2016
• Event Location: Hospital
• Date Manufacturer Received: 04/13/2016
• 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