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

Model Number	N/A
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported the customer had been having difficulty with the catheter and repair kits being used on this patient.This is one of 3 reports being filed for dissatisfaction of alleged cracking of the catheter in relationship to the 1st report filed under medwatch# 1820334-2016-01369.The original medwatch alleged a, ¿(b)(6) years old was being lifted out of a stroller and the catheter cut at the junction between the thin portion and the enlarged portion of the catheter.A repair kit was used on the catheter.¿ monitored the biological parameters of the child.No additional information has been provided regarding patient outcome.The three additional reports are: medwatch 1820334-2016-01480 (this report incident #2).Medwatch 1820334-2016-01478 (incident #3).Medwatch 1820334-2016-01479 (incident#4).
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications and visual inspection of the returned device was conducted during the investigation.One device was returned with the repair kit in place.The length of the catheter measures 33 cm.A visual examination of the repair kit sight, the material is noted to be severed the complete circumference of the device.The point of separation is 26.3 cm from the distal tip.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.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.Measures have been initiated to address this failure mode.We will continue to monitor for similar complaints.

• Brand Name: REDO SINGLE 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: 6180298
• Report Number: 1820334-2016-01480
• Device Sequence Number: 13660165
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)190823(10)7092755
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/28/2017

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-4.0-65-REDO
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 06/28/2017
• 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: 2 YR
• Patient Weight: 11