MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
A (b)(6) male patient was having an unknown procedure when it was discovered that the catheter had a hole and was leaking.It was removed and replaced with a new device.A section of the device did not remain inside the patient's body.No additional procedures were required and the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Investigation - evaluation a review of the complaint history, device history record, specifications, trends and visual inspection of the returned device was conducted during the investigation.The visual / microscopic inspection of the returned device reveals a 4mm rupture of the catheter tubing.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.There is no indication that a design or process related failure mode contributed to this event.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, examination of the returned device and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.
Event or Problem Description
A (b)(6) male patient was having an unknown procedure when it was discovered that the catheter had a hole and was leaking.It was removed and replaced with a new device.A section of the device did not remain inside the patient¿s body.No additional procedures were required and the patient did not experience any adverse effects due to this occurrence.

• Brand Name: REDO DOUBLE LUMEN TPN CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6061798
• Report Number: 1820334-2016-01224
• Device Sequence Number: 13668953
• Product Code: FOZ
• UDI-Device Identifier: 00827002079021
• UDI-Public: (01)00827002079021(17)190324(10)6759072
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-7.0D-65-REDO
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/27/2016
• Supplement Report FDA Received Date: 12/16/2016
• Patient Sequence Number: 1
• Patient Age: 7 YR