MAUDE Adverse Event Report: COOK INC UNKNOWN; CENTRAL LINE CATHETER

Model Number N/A

Device Problems Kinked (1339); Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2017

Event Type  malfunction  

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 Description

International customer reported that a patient was undergoing placement of an unspecified central line catheter using a wire guide.The customer states that "the wire guide unraveled in the patient." no further information was provided.There are no reports of any adverse patient consequence.Additional information was requested; no further information was received as of the date of this report.It is not known if the device is available for evaluation.

Manufacturer Narrative

Cook spectrum minocycline/rifampin impregnated double lumen central venous catheter set.Investigation ¿ evaluation: a review of the drawing, documentation, instructions for use (ifu), manufacturing instructions, and quality control 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.The lot number of the device is not known; accordingly, a review of the device history record could not be conducted.There is no definitive evidence that the device was not manufactured to current manufacturing specifications.The user admits that they were testing the wire prior to patient contact.Per the quality engineering risk assessment no further action is required.

Event Description

Further review of the record clarified that the wire kinked when tested prior to placing in the patient.Please reference mfr.Report: 1820334-2017-01408 for event that was inadvertently reported under this mfr.Report.

• Brand Name: UNKNOWN
• Type of Device: CENTRAL LINE CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6662630
• MDR Text Key: 78497245
• Report Number: 1820334-2017-01481
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UDLM-501J-PED-ABRM-HC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR