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	06/12/2017
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
International customer reported that a patient received a redo single lumen tpn catheter on (b)(6) 2017 for cancer chemotherapy.The patient was in the care of grandparents.The caretakers picked up the patient and stepped on the lines connected to the catheter causing the catheter to break.No further patient or event details are available.It is not known if the device is available for evaluation.It is not known what actions were taken by the clinical staff to address this event.A follow-up report will be submitted if any additional information becomes available.
Additional Manufacturer Narrative
Investigation - evaluation: a review of instructions for use (ifu), complaint history review, device history review, specifications, and visual inspection of the returned device was conducted during the investigation.One partial device was returned for investigation.The catheter measured 1 cm in length.The device was leak tested and no leaks were noted.A visual examination of the device noted no damage to the fitting.The redo single lumen tpn catheter set is shipped with instructions for use (ifu), which clearly states the proper warnings, precautions, and instructions for use with each device.Specifically; ¿silicone catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.If lumen flow is impeded, do not force injection or withdrawal of fluids.Catheter size should be as small as the use will allow¿.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.A thorough review of the device history record did observe one (1) non-conformance that may have contributed to this incident.A complaint history search for similar complaints revealed this record to be the only reported complaint associated with the complaint lot number.Based on the provided information, inspection of returned product, and the investigation, 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.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: 6705590
• Report Number: 1820334-2017-01621
• Device Sequence Number: 16422998
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)191111(10)7347980
• 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,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2017

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-4.0-65-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/14/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 07/12/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR