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

Catalog Number AR13995NR

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the scorpion needle broke inside the patient during patient use.No additional details are available related to the customer reported issue.No serious injury or follow up medical care was reported related to the customer reported issue.The patient was under general anesthesia at the time of the incident, however no additional medication was required.There was no report of any adverse patient consequence, no effect on the patient's stability, and no medical intervention required as a result of the incident.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample was returned for evaluation.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 scorpion needle broke inside the patient during use.

Manufacturer Narrative

One device was received from the end-user facility for evaluation.Upon inspection, it was observed that the tip of the device had broken off.The broken tip was not returned with the device.The reported issue was confirmed.The exact root cause of the device failure could not be determined.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Type of Device: AR-13995N MULTIFIRE SCORPION NDL BLACK
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock avenue; redmond OR 97756
• MDR Report Key: 11723455
• MDR Text Key: 249548270
• Report Number: 3032391-2021-00007
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR13995NR
• Device Lot Number: 439696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Date Manufacturer Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other