MAUDE Adverse Event Report: MEDLINE RENEWAL REPROCESSED SCORPION NEEDLE; SUTURE PASSER

Model Number AR-13995N

Device Problem Material Fragmentation (1261)

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

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

The device in question was returned to for evaluation, and we confirmed that the device had been reprocessed.We performed a thorough inspection and investigation into the incident.We confirmed the reported issue.There were no other device issues observed.The physician decided to leave the tip in the patient.The physician stated that the tip would not cause long term effects on the patient, and that scar tissue would grow around it.There was no report of any patient consequence, nor was additional medical intervention required as a result of this incident.In an abundance of caution, we are filing this medwatch report.

Event Description

We received a report indicating that the tip of a reprocessed scorpion needle detached during use.The physician decided to leave the tip in the patient.

• Brand Name: REPROCESSED SCORPION NEEDLE
• Type of Device: SUTURE PASSER
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer (Section G): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• Manufacturer Contact: brandi panteleon ; 2747 sw 6th st.; redmond, OR 97756
• MDR Report Key: 6408001
• MDR Text Key: 70056139
• Report Number: 3032391-2017-00006
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2018
• Device Model Number: AR-13995N
• Device Lot Number: 275700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention