MAUDE Adverse Event Report: NIRAJ INDUSTRIES PVT. LTD. MYCO MED SUPPLIES, INC.; SCALPEL BLADE

Model Number 6000CST-20

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2018

Event Type  malfunction  

Event Description

Avid medical is the manufacturer of a custom procedure tray (aloc002-01 recovery pack, lot: 1324977) that includes the following component: scalpel #20 w/handle s/s, vendor part # 6000cst-20 supplied by (b)(4) and manufactured by niraj industries (b)(4).Avid medical became aware on 01/10/2019 of a complaint which originated by (b)(6) that involved the scalpel that broke within the body while medical professionals were performing a procedure.The complained scalpel #20 w/handle s/s was not available for evaluation, however 10 blades with the same mfg lot number were submitted to the manufacturer for further investigation.Avid medical issued formal complaint # (b)(4) to the supplier (b)(4) concerning the scalpel that broke during a procedure for item no.6000cst-20, manufacturer lot# 070508.No medical professionals were injured and no patient injury was reported, as this was an organ recovery procedure and the patient was already deceased; however, out of an abundance of caution avid is reporting this event.

• Brand Name: MYCO MED SUPPLIES, INC.
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): NIRAJ INDUSTRIES PVT. LTD.; 177/25 ballabgarh; faridabad haryana; india
• Manufacturer (Section G): AVID MEDICAL INC.; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 9000 westmont drive; toano, VA 23168 ; 8283387568
• MDR Report Key: 8301747
• MDR Text Key: 137014161
• Report Number: 1047429-2019-00002
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6000CST-20
• Device Lot Number: 070508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 02/04/2019
• 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