MAUDE Adverse Event Report: COOK INC. SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER; DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number SCBR5.0-38-100-P-NS-VERT

Device Problem Component(s), broken (1103)

Patient Problem Eye Injury (1845)

Event Date 04/09/2014

Event Type  Injury  

Event Description

A patient underwent a lower extremity angiogram on (b)(6) 2014.The doctor was using the catheter when the hub of catheter broke.Physician was squirted in the face with blood.Another of the same device was used to complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experienced any adverse effects due to this occurrence.

Manufacturer Narrative

Catalog # scbr5.0-38-100-p-ns-vert.(b)(4).Event evaluation: still under investigation.

• Brand Name: SLIP-CATH BEACON TIP HYDROPHILIC ANGIOGRAPHIC CATHETER
• Type of Device: DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): COOK INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3815568
• MDR Text Key: 4452067
• Report Number: 1820334-2014-00191
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Catalogue Number: SCBR5.0-38-100-P-NS-VERT
• Device Lot Number: 4321511
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/22/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/09/2014
• Device Age: 10 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2013
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other