MAUDE Adverse Event Report: COOK, INC. WAYNE PNEUMOTHORAX TRAY; DQR CANNULA, CATHETER

Model Number N/A

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 06/26/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a wayne pneumothorax tube was placed at 10cm.On (b)(6) 2015, the device was noted to be out of the pleural space on ct scan.The catheter had gone back in to the chest wall after pleural space confirmation and drainage.A new thai-quick was placed.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Exp.Date unknown as no lot# was provided.Udi# is unknown as no lot# was provided.(b)(4).The event is currently under investigation.

Manufacturer Narrative

Investigation - evaluation: a review of complaint history, drawing, instructions for use (ifu), manufacturing instructions, quality control and trends was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the device description, precautions and instructions for placement and use of the device.The ifu states step 8, "advance the catheter over the wire guide into the pleural cavity to the desired depth.Depth may be guided by the 2.5cm markings on the side of the catheter.The first mark begins 5 cm after the last side-hole.¿ step 10, "confirm catheter placement by valve movement and fluoroscopic or roentgenographic verification.All connections must be secure and airtight.Perform inspections of the catheter and connections regularly." step 11, "secure catheter in position and the entry site by using a bioocclusive dressing or suturing if desired." step 12, "the catheter and connected drain lines should be secured to the patient.Excessive tension on catheter connections (e.G., in instances of patient movement where the catheter is connected to a vacuum or drainage collection apparatus) may cause catheter/hub separation or accidental catheter dislodgement.To help prevent this from occurring, it is recommended to do one or both of the following: a.Secure the catheter hub to the patient's skin by placing tape, suture or a catheter securement device at the location shown in the illustration below.B.Form a strain relief loop in the connecting tube as shown in the illustration below and secure the loop to the patient's skin with tape, suture, or catheter securement device." the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.The product lot number was not provided a search for production record, non-conformances reported or complaints on the same lot number could not be performed.There is no evidence to suggest that the device was not manufactured to specification.After reviewing the information provided we are unable to determine the root cause of this event.It is possible to suggest that at initial placement that the catheter was not placed at the appropriate depth for the pig tail to form correctly leading to the catheter being out of the pleural space.It is also possible to suggest that based on initial comments from the customer that patient anatomy may have contributed to the difficulty in keeping the catheter at the location it was originally placed.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the health risk assessment, risk to patient and end user is determined to be low, therefore additional risk mitigation activities are not required.

Event Description

On (b)(6) 2015, a wayne pneumothorax tube was placed at 10cm.On (b)(6) 2015 the device was noted to be out of pleural space on ct scan.The catheter had gone back into the chest wall after pleural space confirmation and drainage.A new thal-quick was placed on (b)(6) 2015.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: WAYNE PNEUMOTHORAX TRAY
• Type of Device: DQR CANNULA, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4943562
• MDR Text Key: 16561574
• Report Number: 1820334-2015-00450
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTPTY-1400-WAYNE-112497
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Weight: 108