MAUDE Adverse Event Report: COOK INC Cook Spectrum; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/23/2017
Type of Reportable Event	Serious Injury
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 underwent placement of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter on (b)(6) 2017.The customer states that the center lumen of the triple lumen device with the iv tubing connected was discovered lying in the patient's bed.The circumstances and forces applied to the device leading to the event are not known.The line was immediately removed and a new one inserted.No further event or patient details were provided.The device is reportedly available for evaluation, however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Additional information: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.Investigation-summary: a review of dimensional verification, complaint history, device history record, drawing, ifu, manufacturing instructions, and quality control data was conducted during the investigation.Cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set" (lot 7792182), was returned for evaluation.Visual inspection and dimensional verification of the returned device was performed.The device was returned in used condition; the extension tube with the red hub was separated at the manifold.There was no material inside the manifold.There was a smooth transition of the pin gage through the lumen.The length, outer diameter (od) and inner diameter (id) of the red extension tube were measured and all were within specification.The tubing is insert molded to the manifold and the image of the separation appears to be sheared rather than pulled.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows no nonconforming events which could contribute to this failure mode.A review of complaint history for the product lot revealed this complaint to be the only reported complaint associated to complaint lot number 7792182.Based on the available information and evaluation of the returned device, it is not clear if the leading cause to this event might be associated with intense mobilization of the patient (which could determine an eventual catheter disconnection), the medical procedure or a potential malfunction of the device.However, there is no definitive evidence that the device was not manufactured to specification.While it is feasible that the device may have become kinked or folded or was power injected above predetermined limits causing the tubing to break, the root cause is inconclusive per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: Cook Spectrum
• 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: 6667153
• Report Number: 1820334-2017-01399
• Device Sequence Number: 72660
• Product Code: FOZ
• UDI-Device Identifier: 00827002478251
• UDI-Public: (01)00827002478251(17)200119(10)7792182
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-ABRM-HC-RD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1