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	Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event is currently under investigation.
Event or Problem Description
A (b)(6) female oncology patient removed the catheter herself.The tip was not intact at the time of removal.At insertion, the catheter was measured at 21cm, only 2cm attached to wings found by the bedside nurse.Chest x-ray done to look for the retained device, but the catheter was not seen at the time of the x-ray.Later, the remaining 19cm of catheter was found in the patient's bed.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable or unchanged.(b)(4).Correction: initial was filed within the 30 day time frame regardless of corrected date.Investigation - evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: the device was intended for use by health professionals trained and experienced in catheters as indicated in the precautions of the ifu supplied with the device.The visual inspection of the returned device reported, the device was returned with a securement device.The securement device engaged with the plastic lugs and the returned product still had the securement device attached indicating the patient removed both devices.As the patient is (b)(6) it can be assumed that the device was removed in an uncontrolled manner.The complaint device was returned therefore, an investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.There is no evidence to suggest the product was not made to specifications.Review of 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, the patient removed the device themselves.The device separated during the procedure but did not remain in the body.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
A (b)(6) female oncology patient removed the catheter herself.The tip was not intact at the time of removal.At insertion, the catheter was measured at 21cm, only 2cm attached to wings found by the bedside nurse.Chest x-ray done to look for the retained device, but the catheter was not seen at the time of the x-ray.Later, the remaining 19cm of catheter was found in the patient's bed.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5682343
• Report Number: 1820334-2016-00418
• Device Sequence Number: 10816653
• Product Code: FOZ
• UDI-Device Identifier: 00827002083769
• UDI-Public: (01)00827002083769(17)190202(10)6704284
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2016

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: PICS-301-MPIS
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/04/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/26/2016
• Supplement Report FDA Received Date: 11/01/2016
• 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
• Patient Age: 2 YR