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 Code Available (3191)
Date of Event	11/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported a double lumen catheter, implanted on (b)(6) 2016 for total parenteral nutrition (tpn), was leaking and was replaced with a new one on (b)(6) 2016.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Initial date received by manufacturer is 11/11/2016.Investigation - evaluation: a review of complaint history, device history record, instructions for use (ifu), specifications and visual inspection,were conducted during the investigation.The complaint device was returned in two segments.The hub segment measured 14cm from the point of separation to the y fitting.The catheter segment measured 23 cm from the distal tip to the point of separation.The device was returned used.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.A complaint history review revealed there are two other complaints associated with the complaint lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this issue.Monitoring will continue to be performed for similar complaints.Initial date received by manufacturer is 11/11/2016.Investigation - evaluation: a review of complaint history, device history record, instructions for use (ifu), specifications and visual inspection,were conducted during the investigation.The complaint device was returned in two segments.The hub segment measured 14cm from the point of separation to the y fitting.The catheter segment measured 23 cm from the distal tip to the point of separation.The device was returned used.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.A complaint history review revealed there are two other complaints associated with the complaint lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this issue.Monitoring will continue to be performed for similar complaints.

• 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: 6165743
• Report Number: 1820334-2016-01490
• Device Sequence Number: 377227
• Product Code: FOZ
• UDI-Device Identifier: 00827002079021
• UDI-Public: (01)00827002079021(17)190810(10)7031528
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Received by Manufacturer: 11/14/2016
• Supplement Date Received by Manufacturer: 06/27/2017
• Initial Report FDA Received Date: 12/12/2016
• Supplement Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR