MAUDE Adverse Event Report: COOK, INC. SPECTRUM ANTIBIOTIC IMPREGNATED TRIPLE LUMEN - CUFFED HYPERALIMENTATION CATHETER; FOZ CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number HASTC-8.0-ABRM

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Allergic reaction (1701)

Event Type  Injury  

Event Description

Catheter was placed into a new vessel.The patient developed pain and redness following the placement.A new catheter has been ordered for the replacement.The area rep explained this was not a direct complaint on the device and it was mentioned that it was not believed to be allergic reaction.However, a cook device was involved in the reaction of the catheter being placed into the patient.

Manufacturer Narrative

(b)(4).No product will be returned per information supplied by the customer.Final inspection for multi lumen central venous/hyperalimentation catheter confirms overall catheter surface is clean and free of damage or excessive imperfections.This product is shipped with an ifu which states under "contraindications": "allergy or history of allergy to tetracyclines or rifampiin.Note: because the cook spectrum silicone cuffed central venous catheter is impregnated with a combination of the antimicrobial agents minocycline (a derivative of tetracycline) and rifampin (a derivative of rifamycin b), the contraindications, warning and precautions regarding use of these antimicrobials apply and should be adhered to for use of this device, although systemic levels of minocycline and rifampin in patients receiving this device are highly unlikely to result from their use." / "warnings": " development of a hypersensitivity reaction should be followed by removal of the catheter and appropriate treatment at the discretion of the attending physician." we are inconclusive as to why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Company confidential" a qera was created to assess the risk of this complaint.Per the conclusion of the risk assessment, further risk reduction is recommended, but not required.The benefits of the has catheters outweigh the residual risk, therefore, no further risk reduction will be required.

• Brand Name: SPECTRUM ANTIBIOTIC IMPREGNATED TRIPLE LUMEN - CUFFED HYPERALIMENTATION CATHETER
• Type of Device: FOZ CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita herden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3621468
• MDR Text Key: 16781396
• Report Number: 1820334-2014-00046
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021557
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HASTC-8.0-ABRM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention