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

Catalog Number AK-45703-ACDC

Device Problem Device Handling Problem (3265)

Patient Problem Laceration(s) (1946)

Event Date 10/03/2014

Event Type  Injury  

Event Description

It was reported the procedure was being performed in the anesthesia department.The intern used the retractable safety scalpel to cut the drape and sliced into his pinkie finger requiring stitches.There was no delay in treatment and no pt death or complications reported.

Manufacturer Narrative

(b)(4).

• Brand Name: CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: ARROWGARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTL., INC.; reading PA
• Manufacturer (Section G): ARROW INTL., INC.; 312 commerce pl.; asheboro NC 27203
• Manufacturer Contact: alice harper ; 2400 bernville rd; reading, PA 19605 ; 6103780131
• MDR Report Key: 4162777
• MDR Text Key: 4766074
• Report Number: 1036844-2014-00421
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AK-45703-ACDC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2014
• 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
• Patient Outcome(s): Required Intervention