MAUDE Adverse Event Report: ARROW INTL., INC. CVC SET: 3-LUMEN 7 FR X 30 CM; ARROWGARD CATHETER PRODUCTS

Catalog Number CS-24703-E

Device Problem Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2014

Event Type  malfunction  

Event Description

It was reported that this event occurred in an anesthesia room.During the insertion procedure, the dilator was found damaged.As a result, a new kit was opened and used without.A delay was reported, however, there was no death or complications to the patient as a result of this occurrence.

Manufacturer Narrative

(b)(4).

• Brand Name: CVC SET: 3-LUMEN 7 FR X 30 CM
• Type of Device: ARROWGARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer Contact: alice harper ; 02400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 4288929
• MDR Text Key: 5272565
• Report Number: 1036844-2014-00447
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-24703-E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/06/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: No
• 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