MAUDE Adverse Event Report: US ENDOSCOPY / STERIS CORPORATION CARR-LOCKE INJECTION NEEDLE; ENDOSCOPIC INJECTION NEEDLE

Model Number 00711811

Device Problem Difficult to Flush (1251)

Patient Problem No Information (3190)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

Us endoscopy, 25ga carr-locke injection needle would not flush.Nothing was able to pass through needle, including saline solution.No visible defects were noted.Fda safety report id# (b)(4).

• Brand Name: CARR-LOCKE INJECTION NEEDLE
• Type of Device: ENDOSCOPIC INJECTION NEEDLE
• Manufacturer (Section D): US ENDOSCOPY / STERIS CORPORATION; mentor OH 44060
• MDR Report Key: 8582572
• MDR Text Key: 144268563
• Report Number: MW5086388
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: 00711811
• Device Catalogue Number: 00711811
• Device Lot Number: 1903736
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR