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	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
The international customer reported that the base of the thorax redo single lumen tpn catheter was partially broken.The customer described the break as a rupture of about 5 cm in size, which was observed to exist at the point where the catheter exits from the patient's skin.The patient's chemotherapy was suspended for 12 hours as a result, and the patient contact called the surgeon to fix it with a repair kit.The catheter had originally been implanted on (b)(6) 2017.The catheter was not used in a high flow or power injection indication, and the syringe used to flush the catheter was never less than 10 ml.The device is reportedly unavailable for return and evaluation.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is previously submitted, unknown, or unavailable.Additional information/corrected data: after further review of the record, it was determined that additional information received identified, that per the representative, regarding the device repair and/or replacement, "after the repair it was necessary to continue with the chemotherapeutic therapy; as soon as possible, if i am not wrong 48/72 hours later, he has been replaced with a new one".It was also clarified that 1) cse means: self transplantation stem cells and 2) the cvc implantation was on 20th july and the first kit (repair) has been used 5 months later ca [sic].Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), quality control, and trends 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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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.A review of the device history record found no other non-conformances associated with the complaint device lot number (7534106).A review of the manufacturer's complaint database found five other complaints associated with the complaint device lot number (7534106).These complaints are related to a single patient and one device.Ifu c_t_tpn_rev6, instructions for use: warnings - if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions - silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance - if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Strict aseptic technique must be adhered to while using and maintaining catheter.How supplied - upon removal from package, inspect the product to ensure no damage has occurred.Based on the provided information a definitive root cause cannot be established or reported at this time.This failure mode was escalated per internal processes and it was determined per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.H3 other text : blank fields on this form indicate the information is previously submitted, unknown, or unavailable.Additional information/corrected data: after further review of the record, it was determined that additional information received identified, that per the representative, regarding the device repair and/or replacement, "after the repair it was necessary to continue with the chemotherapeutic therapy; as soon as possible, if i am not wrong 48/72 hours later, he has been replaced with a new one".It was also clarified that 1) cse means: self transplantation stem cells and 2) the cvc implantation was on 20th july and the first kit (repair) has been used 5 months later ca [sic].Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), quality control, and trends 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.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.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.A review of the device history record found no other non-conformances associated with the complaint device lot number (7534106).A review of the manufacturer's complaint database found five other complaints associated with the complaint device lot number (7534106).These complaints are related to a single patient and one device.Ifu c_t_tpn_rev6, instructions for use: warnings - if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions - silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance - if catheter is not to be used immediately, its lumen should be maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Catheter lock should be reestablished after every use or at least every 24 hours if unused.Strict aseptic technique must be adhered to while using and maintaining catheter.How supplied - upon removal from package, inspect the product to ensure no damage has occurred.Based on the provided information a definitive root cause cannot be established or reported at this time.This failure mode was escalated per internal processes and it was determined per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7325519
• Report Number: 1820334-2018-00604
• Device Sequence Number: 11164163
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)200119(10)7534106
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2018

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: Lay User/Patient
• 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: 02/13/2018
• Supplement Date Received by Manufacturer: 05/03/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 05/03/2018
• 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