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.

Manufacturer Narrative

On (b)(6) 2020 unused product samples in unopened packaging from the reporting facility were received for evaluation.The unused product samples were from lots: 438408, 439083, 434082, 437268, and 433286.The used device involved in the incident was reportedly discarded an unavailable for return and evaluation.No issues were observed with the returned unused product samples.A review of the device history record for the returned lots was performed and no non-conformances in required processes at the time of reprocessing were identified.A root cause for the reported incident was unable to be determined.If additional relevant information becomes available another supplemental mdr will be filed.

• Type of Device: AR-13995N @MULTIFIRE SCORPION NDL
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond, or
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• 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: Health Professional
• Device Catalogue Number: AR13995NRH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other