MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN® SAFETY; I.V. SAFETY CATHETER

Model Number 4251601-020

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2023

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in netherlands: "ivc catheter broken? (shorter normal)".According to the customer: "reason of complaint: by removing the ivc catheter, the nurse found out that the ivc catheter shorter was than normal.Maybe there is a piece from the catheter left behind in the patient.The doctor examined the patient but could not found anything".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).Summary of root cause analysis: · received 1 pc used capillary hub of int.Safety-w pur 24g 0.7x14mm-eu(x) without packaging and the tear off part of the capillary was not returned.· observed the capillary was cut off approximately 9 mm away from the capillary housing.· the cut off surface area exhibits clean cut and even surface.Manufacturing process review.Manufacturing process was reviewed and there are detections for short length capillary at both cal and ecm machine vision system.The station is highlighted in below process flow.Simulation 1: a simulation was conducted by cutting a capillary to a shorter length and passed it through catheter present check station.The sensor detected error and cannot proceed to run.Simulation 2: simulation 2 was conducted by cutting a capillary to a shorter length and passed it through catheter leakage test station.The sensor detected error and the simulation sample will be rejected at reject station.Simulation 3: simulation 3 was conducted by cutting a capillary to a shorter length and test at both cal and ecm machine vision system.The sample was able to be detected and was rejected.Simulation 4: simulation 4 was conducted by purposely try to break off the capillary under different scenarios.Scenario 1 - pierce by cannula a simulation was conducted by using a good part and piercing the capillary with cannula and later tear off the capillary.This defect is similar to cannula reinsertion where the cannula would pierce the capillary and cause it to be broken apart.The simulation sample was taken for inspection and observed that defect created was not similar to complaint sample.The capillary broken area exhibits a clear "v" shape cut from the cannula bevel.Scenario 2 - cut by scissors a good sample capillary was cut by scissors and take the sample for inspection.The cut area exhibits an even surface and clean cut.It is similar with the complaint sample.Conclusion · the cut off surface area of complaint sample is similar with simulation in scenario 2 - cut by scissors.· as mentioned in ifu warning section: do not use scissors or sharp instruments at or near the insertion site.Cause: defect due to wrong handling (referring to application error or off-label use) justification: not confirmed device history record (dhr): reviewed the device history record for batch number 20m22g8315 and there was no defect encountered during in process and final control inspection.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: INTROCAN® SAFETY
• Type of Device: I.V. SAFETY CATHETER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17262045
• MDR Text Key: 318516300
• Report Number: 9610825-2023-00306
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251601-020
• Device Catalogue Number: 4251614-01
• Device Lot Number: 20M22G8315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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