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U.S. Department of Health and Human Services

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

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MEDLINE RENEWAL AR-13995N @MULTIFIRE SCORPION NDL Back to Search Results
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.
 
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Type of DeviceAR-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 Key10407953
MDR Text Key204026678
Report Number3032391-2020-00011
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAR13995NRH
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 Received09/09/2020
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
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