MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. 3-L CVC KIT: 7 FR X 16 CM; ADULT MULTI LUMEN CATHETER PRODUCTS

Catalog Number ASK-12703-WMC1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 04/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).No sample will be returned for evaluation.

Event Description

It was reported the procedure was being performed in the icu.The inserting physician cut himself with the deroyal #11 retractable safety scalpel in the kit after attempting to reuse it.There was no harm to the patient.The physician did not require medical attention except for follow up status post blood born pathogen evaluation.He reused the scalpel to make the incision bigger.

• Brand Name: 3-L CVC KIT: 7 FR X 16 CM
• Type of Device: ADULT MULTI LUMEN CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5657992
• MDR Text Key: 45276534
• Report Number: 1036844-2016-00264
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: ASK-12703-WMC1
• Device Lot Number: 23F15M0862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2015
• 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