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	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient received a redo single lumen tpn catheter for treatment of leukemia.The customer reported that the catheter broke 'involuntarily' at an unspecified time following initial placement.The event occurred at the home of the patient.There are no reported adverse patient consequences.The conditions and handling circumstances at the time of the event are not known.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.Additional device repair or replacement information and patient outcome details were requested.
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient received a redo single lumen tpn catheter for treatment of leukemia.The customer reported that the catheter broke 'involuntarily' at an unspecified time following initial placement.The event occurred at the home of the patient.The device was removed and replaced with a new device.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, and a visual inspection was conducted during the investigation.One partial device was returned and visual examination noted a hole in the base of the taper.Per the instructions for use: extreme caution must be used in placement and monitoring of catheters.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.If lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter size should be as small as the use will allow.Review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.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.Based on the provided information a definitive root cause cannot be established or reported at this time.We will notify the appropriate personnel and continue to monitor for similar complaints.Measures have been previously initiated to address this issue.Per the quality engineering risk assessment no further action is required.

• 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: 6683953
• Report Number: 1820334-2017-01648
• Device Sequence Number: 1973143
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)191104(10)7322630
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2017

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/29/2017; 09/11/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 07/27/2017; 09/27/2017
• 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