MAUDE Adverse Event Report: UNISIS CORP. UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE; SPINAL NEEDLE

Catalog Number 115107

Device Problem Bent (1059)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/17/2014

Event Type  Other  

Event Description

On (b)(6) 2014, lumbar puncture was conducted with (b)(6) girl.Suspicion: neuroborreliosis.During procedure, needle bent and caused problems in collecting csf for further studies.Difficult to put in of the needle under appropriate angle which caused add'l puncture of the pt.

Manufacturer Narrative

We will submit the follow up report as soon as we finish investigation.

• Brand Name: UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): UNISIS CORP.; tokyo ; JA
• Manufacturer (Section G): SAITAMA FACTORY; 2623-1, nishikata, koshigaya-shi; saitama 342- 0822; JA 342-0822
• Manufacturer Contact: 2623-1, nishikata, koshigaya-shi; saitama 342-0-822 ; 89908250
• MDR Report Key: 3810268
• MDR Text Key: 18932817
• Report Number: 9681709-2014-00005
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/07/2014

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: Health Professional
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 115107
• Device Lot Number: 13B015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5.5 YR
• Patient Weight: 37