MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR

Model Number 4251130-03

Device Problems Fail-Safe Problem (2936); Material Deformation (2976)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/23/2023

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in malaysia: "stylet was bend after inserting".According to the customer: "when did the failure occur: after therapy.Reason of complaint: found the stylet was bend after inserting the branula and the safety clip did not retract to protect the sharp point.Staff gor pricked with exposed sharp point of the stylet.".

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 2023-11-09.Device history record (dhr): reviewed the device history record for batch number 23b19g8933 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no samples returned but nevertheless a photo is being attached in cc notification.From the photo provided, it can be observed that the sample is badly damaged / bent and the cannula tip is broken.Further evaluation and investigation will be performed based on the picture.This complaint shall also be taken to the knowledge and filed for statistical purpose.Nevertheless, if the complaint sample is available and being returned, hence complaint will be re-open and re-investigated accordingly.Note: complaint flow to production.Object part cannula.Task for (b)(4): review of batch history records.Status: task completed.Dhr reviewed.Task for (b)(4): no sample(s).Status: task completed.No samples, pictures attached in cc.Task for (b)(4): awaiting statement.Status: task completed.Root cause analysis: machine production completion date packing s/packet : 12137844.Packing machine f69, 2023-02-20.Eto channel : steris, 2023-03-07.Final shop packet no: 12138020.Batch: 23b19g0g03.Article no : 4251130up.Cam d962, 2023-02-19.Cal d963, 2023-02-19.Ecm d964, 2023-02-19.Process cards show no abnormalities.Trending analysis: customer complaint on cannula - bend for introcan safety 3 trend.Analysis is being tracked based on capa initiation criteria.Summary of root cause analysis: received a picture of cannula hub of introcan safety 3 pur 20g 1.1x32mm-ap product without packaging.Observation on the picture shows that the cannula was bent and curve from the cannula hub onwards.The needle tip was exposed and the clip dislodged.The catheter hub and protective cap cannot be observed in the picture received.Since there is no sample returned, the investigation will be based on the picture given.Picture of complaint sample: ecm process flow.The process mapping for introcan safety 3 end control machine has been viewed and possible station that might induce similar defect is highlighted station as below: ecm process flow: simulation 1: simulation was carried out at the catheter to cannula assembly station of introcan safety 3 end control machine by creating a simulation sample with cannula bend defect and proceed to assembly process.The catheter hub cannot be assembled to the simulation sample and the sample was then rejected as reject station.Simulation sample 1: catheter to cannula hub assembly station.Simulation 2: a simulation was conducted at feeding and assembly of protective cap station by creating a similar defect as per return sample picture and pass it through the assembly process.When the protective cap assembly station was misaligned from 1mm till 3mm, there was no damage (neither bend cannula nor damage protective cap) encountered.When the protective cap assembly station was misaligned from 4mm onwards, the cannula folded and damage at inner surface of protective cap.The protective cap cannot be assembled to the simulation sample and at the protective cap inspection the part will be rejected and not further processed.Simulation samples 2: after assembled with protective cap.Protective cap inspection: simulation 3: the simulation was performed by removing the cannula from the catheter hub with force in an extreme angle.The cannula was hold toward upward while removing the cannula from the catheter hub.The cannula was found bent more than 2 degrees (out of specification).Removing the cannula from the catheter hub with force in an extreme angle might contribute to bending of the cannula.Result: found the needle tip was exposed and the clip dislodged.The simulation samples are identical with received picture.Simulation sample 3: simulation 4: simulation 4 was performed by applying external force on the points shown below.Improper removing of protective cap might contribute to bending of the cannula.The outcome cannot be concluded as the sample not returned by the customer for further investigation.Simulation 4 sample conclusion : during simulation no damaged found at all components for misalignment for 3mm and below.For misalignment 4mm and above, minor damages found at protective cap.Besides that, bent cannula happened for misalignment 4mm and above.This resulted protective cap cannot be assembled.Observed bend defect, needle tip exposed and the clip dislodged on the simulation 3 by removing the cannula from the catheter hub with force in an extreme angle.The simulation samples are identical with received picture.The defects is not indicative to manufacturing failure and the actual sample involved in the event was not available for evaluation.Without the actual sample, further evaluation was not possible, and the exact cause of the event could not be determined.Therefore, this complaint concluded as not confirmed.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.

• Brand Name: INTROCAN SAFETY® 3
• Type of Device: CATHETER,INTRAVASCULAR
• 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: 18241483
• MDR Text Key: 330559500
• Report Number: 9610825-2023-00547
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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
• Report Date: 11/30/2023

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: Health Professional
• Device Model Number: 4251130-03
• Device Lot Number: 23B19G8933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2023
• 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