MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE E-CATH ACC. TSUI; CATHETER, CONDUCTION, ANESTHETIC

Model Number 251285-40E

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

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

Event Date 08/03/2020

Event Type  malfunction  

Event Description

Missing piece on the nerve block catheter allowing the external catheter to slide on the needle resulting in shearing of the catheter.

• Brand Name: E-CATH ACC. TSUI
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; 6611 bay circle, suite 140; norcross GA 30071
• MDR Report Key: 10487491
• MDR Text Key: 205485362
• Report Number: 10487491
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 04048223037348
• UDI-Public: (01)04048223037348
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2020

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: Other
• Device Model Number: 251285-40E
• Device Catalogue Number: 251285-40E
• Device Lot Number: 1322
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1