MAUDE Adverse Event Report: UNISIS CORP. DAHLHAUSEN; SPINAL NEEDLE

Model Number 52804500

Device Problem Break (1069)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

The spinal needle was used for lamber puncture and the tip broke in the patient back.According to our information of the outcome of the patient, the patient was shortly immobilized hard painful but no lasting effect expected.

Event Description

The spinal needle was used for lamber puncture and the tip broke in the patient back.According to our information of the outcome of the patient, the patient was shortly immobilized hard painful but no lasting effect expected.

• Brand Name: DAHLHAUSEN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): UNISIS CORP.; 2675-1 nishikata; koshigaya city, 343-0 822; JA 343-0822
• MDR Report Key: 9308511
• MDR Text Key: 204718829
• Report Number: 9681709-2019-00007
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• PMA/PMN Number: K983858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 52804500
• Device Lot Number: 17A200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1