MAUDE Adverse Event Report: ARROW INTL., INC. 3-L CVC KIT: 7 FR X 20 CM; ADULT MULTI-LUMEN CATHETER PRODUCTS

Catalog Number CDC-15703-1A

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2014

Event Type  malfunction  

Event Description

It was reported that this event occurred in the surgery department while the catheter was in use.Prior to starting the liver case, the physician tried to flush and aspirate all three lumens.The physician noticed that only the brown (distal) lumen would flush; the blue and white lumens would not flush.When the physician removed the catheter, she tried to flush the lumens and was only able to flush the brown (distal) lumen; it appeared that the blue and white lumens were occluded.As a result, the physician removed and replaced the catheter to successfully complete the procedure.There was a delay reported, however, there was no harm, complication, death, or injury reported to the pt as a result of this occurrence.The event was initially evaluated and determined to be non-reportable.The returned device was reviewed and the event was determined to be the result of a product malfunction, therefore, it is reportable.

Manufacturer Narrative

(b)(4).

• Brand Name: 3-L CVC KIT: 7 FR X 20 CM
• Type of Device: ADULT MULTI-LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: jody cadd, reg affairs ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4148046
• MDR Text Key: 4767296
• Report Number: 1036844-2014-00409
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: CDC-15703-1A
• Device Lot Number: 23F13J0341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1