MAUDE Adverse Event Report: UNISIS CORP.; SPINAL NEEDLE

Model Number 52514620

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

After spinal anesthesia puncture with a needle 27g, the needle broke leaving a 1cm piece subcutaneous, being apart of the piece housed intervertebral.Child was forwarded to a general hospital for image exams with withdrawal body by a neurosurgeon.Because of the incident, the orthodopexy was not performed.

• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): UNISIS CORP.; 2675-1 nishikata; koshigaya, saitama 31308 22; JA 3130822
• Manufacturer (Section G): UNISIS CORP; 2675-1 nishikata; koshigaya, saitama 34308 22; JA 3430822
• Manufacturer Contact: yoshikazu matsumoto ; 2623-1 nishikata; koshigaya, saitama 34308-22 ; JA 3430822
• MDR Report Key: 9965912
• MDR Text Key: 190949311
• Report Number: 9681709-2020-00001
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K983858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 52514620
• Device Lot Number: 17L111
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1