MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
Information for this report was received from the european competent authority mhra.The report indicates that a patient had a single lumen peripherally inserted central venous catheter (picc) implanted through a right axillary approach.The date of initial implantation and duration of clinical use was not provided.The report states that the patient was in a bouncer chair and became agitated.When the staff nurse attended to the child, it was noted that the picc line from the right axilla was lying on the floor the clip (securacath) for securing the picc line in place remained in-situ.The staff nurse was not sure if the device found lying on the floor accounted for the entire device or if a portion had fragmented and remained retained in the patient; the nurse indicates there are no demarcations on the device.The patient was taken for x-rays to rule out any retained foreign objects.The results of the x-ray analysis were not provided.No further information is available relating to the event and patient condition.It was not reported if a new device was implanted.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, instructions for use (ifu), quality control, and specifications of the device was conducted during the investigation, and no issues were found related to the reported issue.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 no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.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: SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS 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: 6361087
• Report Number: 1820334-2017-00347
• Device Sequence Number: 10772777
• Product Code: FOZ
• UDI-Device Identifier: 00827002032651
• UDI-Public: (01)00827002032651(17)180914(10)6204816
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PICS-301J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 MO