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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
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
Customer reported that a patient received a redo single lumen tpn catheter on an unspecified date.The customer reported that the central line is "about to break".Pediatric surgery was called and the line was repaired at bedside.There was no medical or surgical intervention to address this event.The circumstances and handling conditions that lead up to the event are not known.The device is still in clinical use, accordingly it is not available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, instructions for use (ifu), specifications and quality control data was conducted during the investigation.The complaint device has not been returned for investigation, therefore; an analysis is unavailable at this time.It was reported the patient did not experience any ¿adverse effects¿ however, an additional procedure(s) was required; to ¿repair the line¿, due to this occurrence.The redo single lumen tpn catheter set is shipped with instructions for use, which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿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.A definitive root cause could not be determined, however; based on the provided information the actual root cause is deemed to be ¿inconclusive¿.A complaint history search for similar complaints revealed this record to be the only reported complaint associated with the complaint lot number: 7464353.A thorough review of the device history record did not observe any non-conformances that may have contributed to this incident associated with the complaint lot number; 7464353.Based on the investigation evaluation, 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.We will notify the appropriate personnel and continue to monitor for similar complaints.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: 6670050
• Report Number: 1820334-2017-01503
• Device Sequence Number: 16414058
• Product Code: FOZ
• UDI-Device Identifier: 00827002079601
• UDI-Public: (01)00827002079601(17)191214(10)7464353
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2017
• Supplement Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 06/27/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO