MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; ANESTHESIA CONDUCTION KIT

Model Number 570245

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/25/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: event 1: brief inquiry description "broken nerve block catheter".Detailed inquiry description twice now this product has broken off in a patient.No injury reported.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number (b)(4).  no sample and/or lot number were provided.Further investigation of the complaint is not possible without a sample and/or lot number.  we will maintain this report for further references and continue to monitor other reports for similar occurrences.  if any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: DESIGN OPTIONS®
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13710205
• MDR Text Key: 286853959
• Report Number: 2523676-2022-00104
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 04046964526664
• UDI-Public: (01)04046964526664
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 570245
• Device Catalogue Number: 570245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention