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	11/26/2017
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
The international customer reported that the redo single lumen tpn catheter "sectioned after the safety loop when the patient got up" and "was cut by accident" [sic].This resulted in an interruption of the "sal transfusion" [sic] in progress for an hour, and additionally necessitated the placement of a peripheral venous access for infusing treatments while the catheter was repaired.The patient reportedly did not experience any adverse events as a result of the product malfunction.Additional information has been requested from the customer, but none has yet been made available.The device is reportedly not available for return and evaluation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were five other reported complaints for this lot number.Clinical assessment:there is no information regarding the circumstances leading up to the device being cut.There is no information regarding how the device was secured to the patient.There is no information regarding the patient environment that may have contributed to this event.Per the customer, the patient got up.Getting up could have caused tension on the c-tpns-4.0-65-redo causing to the event.The device will not be returned for evaluation.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.At this time, the clinical assessment cannot eliminate any possible causes for this event such as device maintenance, patient environment, patient mobility, device failure, or manufacturing related causes./ based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.This failure mode has been escalated per internal processes.

• 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: 7176671
• Report Number: 1820334-2018-00066
• Device Sequence Number: 1888412
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)200119(10)7534106
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2018

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-4.0-65-REDO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 03/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1