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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/17/2017
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
The customer reported that, when the operator was injecting saline through the single lumen peripherally inserted central venous catheter (picc), some of the saline proceeded to squirt through a defect in the picc and into the operator's eye.The picc line was then removed from the patient.The defect was observed to be approximately 4 cm away from the injecting hub of the line.The line was reportedly inserted uneventfully on (b)(6) 2017, and had been used without complication up until that point.The device is reportedly unavailable for return.
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.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: 7015304
• Report Number: 1820334-2017-03797
• Device Sequence Number: 19188342
• Product Code: FOZ
• UDI-Device Identifier: 00827002032668
• UDI-Public: (01)00827002032668(17)200423(10)7853356
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PICS-401J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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