MAUDE Adverse Event Report: CAREFUSION SAFE-T-CENTESIS TRAY 6FR X 16CM; NEEDLE, CATHETER

Model Number PIG1260T

Device Problem Air Leak (1008)

Patient Problem Pneumothorax (2012)

Event Date 02/07/2014

Event Type  Injury  

Event Description

Dr (b)(6), is concerned because he had a patient develop a pneumothorax recently with our device. on (b)(6) 2014, the sales representative provided the following additional information as obtained from dr (b)(6).There was nothing unusual about the device used or the procedure itself, and all went smoothly otherwise.The patient was admitted and treated with a chest tube.The issue with the catheter is that air began entering the pleural space after the needle had been completely removed from the catheter and while withdrawing fluid.  reportedly, this would imply the valve or other part of the device allowed the air in. on (b)(6) 2014, the sales representative also indicated that during the procedure, the catheter/ needle did not need to be reinserted for placement; the insertion was straightforward and smooth.

Manufacturer Narrative

(b)(4).Investigation results: three (3) unopened units of catalog code pig1260t, lot number 0000611116 and one (1) opened unit of product catalog code pig1260t comprising of a luer-lock 60ml syringe, a universal drainage set and a 6fr safe-t-centesis catheter drainage device (unknown lot number), were received for evaluation.Examination of all four (4) catheter assemblies did not reveal any manufacturing or functional defects that may have led to the reported issue.Functional testing was able to confirm the catheter assemblies drained as intended.In addition, no leaks were detected during functional testing.The sample analysis was unable to confirm the reported issue.A review of applicable manufacturing, inspection, and packaging procedures did not identify any issues that may have contributed to the reported issue.The quality plan includes inspection points for the veress safety needle assembly.No deficiencies were identified with these inspections during the manufacture of the reported lot.Likewise, a review of all manufacturing methods and personnel involved in the assembly of the device determined there was no contribution from either to the reported issue.A review of all materials used in the assembly of this device did not identify any issues with any component that may have contributed to the reported issue.The catheter valve assembly is supplied by an external supplier and is not altered by the carefusion-mannford manufacturing facility prior to placement in the finished tray.Consequently, the investigation determined the materials used in manufacture of the product did not contribute to the reported issue.Based on the investigation results, a definitive root cause could not be identified.No manufacturing, assembly or performance deficiencies were noted on the samples received for analysis.The supplier of the catheter valve assembly will be notified of this failure mode via a supplier quality notification in an effort to heighten awareness and minimize impact from the manufacturing processes.Although the reported issue could not be replicated with the samples received for analysis and the most probable root cause could not be determined, the manufacturing plant will continue to monitor this issue to identify the need for any further actions.

Manufacturer Narrative

(b)(4).

Event Description

On 03/28/2014, the physician indicated that to the best of his knowledge, there were no sequelae of the pneumothorax aside from a short hospitalization.

• Brand Name: SAFE-T-CENTESIS TRAY 6FR X 16CM
• Type of Device: NEEDLE, CATHETER
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 3666494
• MDR Text Key: 4346889
• Report Number: 1625685-2014-00109
• Device Sequence Number: 1
• Product Code: GCB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: PIG1260T
• Device Lot Number: 0000611116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2014
• 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): Required Intervention