MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; IV CANNULAE

Model Number 4254503-03

Device Problem Break (1069)

Patient Problems Scar Tissue (2060); Foreign Body In Patient (2687)

Event Date 12/17/2023

Event Type  Injury  

Event Description

As reported by the user facility information by (b)(6) in china: "capillary was broken".According to the complainant on (b)(6) 2023, the patient was admitted to the hospital for treatment.On (b)(6) 2023, the patient was ready to be discharged and the indwelling needle was removed.Reportedly during the removal, it was found that the capillary was broken.A procedure was performed to remove the capillary on an unspecified date.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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.Bmi complaint management dated 2023-12-19.Device history record (dhr): reviewed the device history record for batch number 23b16g8391 and there were no defect encountered during in process and final control inspection.Note: awaiting for sample from china.Sample receipt at bmi - complaint investigator, dated 2023-12-27.Bmi preliminary investigation: received 1 used and contaminated capillary hub of an introcan safety-w fep 24g, 0.7x19mm-ap without packaging.Attached with the returned sample was an extension set presumably used with the product.Cannula hub and protective cap were not being returned for investigation.Based on test spec #: (b)(4) (introcan sterile), took the sample to a visual test according to test method 102000 (visual) | test method 102002 (damages) and observed that the capillary was damaged/broken off.Note: forwarded the sample to inv for further evaluation and investigation.Process cards show no abnormalities summary of root cause analysis: received 1pc capillary housing without cannula hub and protective cap of introcan safety-w fep 24g, 0.7x19mm without packaging.· the sample was taken for investigation and observed the capillary was tear off approximately 2mm from the capillary hub horn.The torn of piece was measured and the length is approximately 17mm.Complaint sample: the sample was taken for visual inspection for thorough inspection.Visual inspection: summary: observed a v cut on the capillary.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: another simulation was conducted by purposely try to break off the capillary under different scenarios.Scenario 1 - pierce by cannula: a simulation was conducted by piercing the capillary with cannula and pull off the capillary apart and compare the defect created with the complaint sample.The simulation sample exhibits a "v" shape cut at the capillary broken area as a result of being cut by the cannula bevel similar to the complaint sample.The defect created was similar to complaint sample.Scenario 2 - cut by sharp objects: a good sample capillary was cut by sharp objects and take the sample for inspection.The cut area showing a clean cut of the capillary.Result: simulation sample was not similar with the complaint sample.Scenario 3 - clamp by vein clamp: a good sample capillary was clamped by vein clamp and break the capillary apart.The sample was taken for inspection.The capillary broken area was in uneven shape, the capillary was folded, and it was stretched.The defect created was not similar to the complaint sample.Cause : defect due to wrong handling.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: machine production completion date.Packing s/packet : 12134647.Packing machine f66 2023-02-16.Eto channel steris 2023-03-02.Final shop packet no: 12134706.Batch: 23b08g0009.Article no : 4254503up2.Cam d822 2023-02-08.Cal d895 2023-02-08.Ecm d882 2023-02-08.Process cards show no abnormalities trending analysis: customer complaint of capillary damage - tear off for introcan trend analysis is being tracked based on capa initiation criteria.Summary of root cause analysis: · received 1pc capillary housing without cannula hub and protective cap of introcan safety-w fep 24g, 0.7x19mm without packaging.· the sample was taken for investigation and observed the capillary was tear off approximately 2mm from the capillary hub horn.· the torn of piece was measured and the length is approximately 17mm.The sample was taken for visual inspection for thorough inspection.Summary: observed a v cut on the capillary 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: another simulation was conducted by purposely try to break off the capillary under different scenarios.Scenario 1 - pierce by cannula · a simulation was conducted by piercing the capillary with cannula and pull off the capillary apart and compare the defect created with the complaint sample.· the simulation sample exhibits a "v" shape cut at the capillary broken area as a result of being cut by the cannula bevel similar to the complaint sample.· the defect created was similar to complaint sample.Scenario 2 - cut by sharp objects a good sample capillary was cut by sharp objects and take the sample for inspection.The cut area showing a clean cut of the capillary.Result: simulation sample was not similar with the complaint sample.Scenario 3 - clamp by vein clamp · a good sample capillary was clamped by vein clamp and break the capillary apart.The sample was taken for inspection.· the capillary broken area was in uneven shape, the capillary was folded, and it was stretched.· the defect created was not similar to the complaint sample.Cause : defect due to wrong handling (referring to application error or off-label use).Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.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: IV CANNULAE
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18521248
• MDR Text Key: 332952881
• Report Number: 9610825-2023-00688
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4254503-03
• Device Lot Number: 23B16G8391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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