MAUDE Adverse Event Report: COOK INC REDO DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Partial Blockage (1065); Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2017
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 pediatric patient presented to the emergency room on (b)(6) 2017 with a broken redo double lumen tpn catheter.The catheter was intended for long term tunneled broviac use and had been placed on (b)(6) 2017.The break reportedly occurred at the point of bifurcation between two separate lumens.On inspection, it was observed that the sutures were not pulled, the dressing was intact, and the end of the line was straight clean cut.The double lumen section which had come off of the catheter had already been discarded by the patient's caregiver.The line was repaired using a repair kit.The lumens reportedly did not flush easily thereafter, so 1 mg cathflo was instilled in each lumen overnight.The patient returned the following morning for blood work and a follow up.No additional patient consequences have been reported.
Additional Manufacturer Narrative
Investigation - evaluation: a review of complaint history, device history record, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.However, a document review was conducted.Based on the document review, 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.A review of the manufacturer's complaint database found this to be one of two complaints associated with the complaint device lot number (same lot, same device, different failure modes).This complaint is confirmed based on the customer's testimony.Based on the provided information a definitive cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: REDO DOUBLE 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: 7031573
• Report Number: 1820334-2017-03936
• Device Sequence Number: 1051144
• Product Code: FOZ
• UDI-Device Identifier: 00827002079021
• UDI-Public: (01)00827002079021(17)200404(10)7647067
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2018

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-7.0D-65-REDO
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2017
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1