MAUDE Adverse Event Report: MEDLINE RENEWAL AR-13995N @MULTIFIRE SCORPION NDL

Catalog Number AR13995NRH

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified procedure, the tip of the scorpion needle broke off and fell into the surgical site. Despite multiple good faith-attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information. No information has been provided related to how the scorpion needle was being used at the time of the incident or how the broken tip was retrieved from the surgical site. No adverse impact to the procedure or to the patient has been reported. No sample was returned for evaluation. A root cause for the reported incident was unable to be determined. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the scorpion needle broke off and fell into the surgical site.

• Type of Device: AR-13995N @MULTIFIRE SCORPION NDL
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond, or
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 10407953
• MDR Text Key: 204026678
• Report Number: 3032391-2020-00011
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: AR13995NRH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/14/2020 Patient Sequence Number: 1