MAUDE Adverse Event Report: MEDLINE RENEWAL; AR-13991N @SUREFIRE SCORPION NDL

Catalog Number AR13991NR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that multiple needles broke during use with a patient during the same procedure.The procedure is reportedly unknown.The facility was able to retrieve all of the needles and disposed of them in a sharps container.No actual sample is available to be returned for evaluation.No additional information is available.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.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 multiple needles broke during use with a patient during the same procedure.

• Type of Device: AR-13991N @SUREFIRE SCORPION NDL
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11065063
• MDR Text Key: 223396306
• Report Number: 3032391-2020-00016
• 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: Other
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR13991NR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention