MAUDE Adverse Event Report: CAREFUSION SAFE-T-CENTESIS CATHETER DRAINAGE TRAY, 6 FR

Model Number PIG1260T

Device Problems Air Leak (1008); Connection Problem (2900)

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

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Medical specialties - leak customer stated "catheter had air leak, same issue has happened multiple times over the past few months.When covering it up with a finger the leak stopped.They tried to use tape, but unsuccessful.(b)(6) 2014 additional information received from customer;   the issue happened during patient use.There was no harm to the patient.We were doing a paracentesis.The procedure was completed, we just had to alter the connection to the vacutainer bottles.(b)(6) 2014 clarification of the altering of the connection--they had to remove tubing with the valve on it.

Manufacturer Narrative

(b)(4).A complaint sample was not provided for evaluation.The investigation was unable to confirm the reported failure mode through visual inspection of the photograph provided by the customer.Examination of the photograph did not identify any manufacturing defect or malfunction that could have contributed to the reported failure mode.Any potential contributor could not be evaluated further due to a lack of investigation evidence.A 24-month review of complaint data (11/1/2012 ¿ 10/31/2014) has identified that this failure mode is not an isolated event.A review of all methods and personnel used in the assembly of the device did not identify any issues that may have contributed to the reported failure mode.Consequently, the investigation determined no contribution of manufacturing personnel to the reported complaint failure mode exists.A thorough review of applicable manufacturing procedures and quality plan inspections did not identify any issues that may have contributed to the reported failure mode.The catheter valve assembly is supplied by an external vendor ((b)(4)) and is not altered by (b)(4) prior to assembly into the finished tray.Consequently, the investigation determined no contribution of the manufacturing processes to the reported complaint failure mode exists.

• Brand Name: SAFE-T-CENTESIS CATHETER DRAINAGE TRAY, 6 FR
• Type of Device: SAFE-T-CENTESIS CATHETER DRAINAGE TRAY, 6 FR
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4330681
• MDR Text Key: 5256849
• Report Number: 1625685-2014-00141
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PIG1260T
• Device Lot Number: 0000687244
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2014
• 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