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

Model Number 4253540-01

Device Problem Fail-Safe Problem (2936)

Patient Problem Exposure to Body Fluids (1745)

Event Date 01/16/2024

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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 information by bbm sales organization in france: "closing system-failed to engage" according to the customer: accident exposure to blood, prick type with an intravenous catheter.The prick happened during the elimination of waste linked to this treatment.Incident declared to authorities because the safety of the catheter was not fully triggered.Immediate care provided.Patient serology collected.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr): reviewed the device history record for batch number 23e10g8912 and there were no defect encountered during in process and final control inspection.Machine production completion date.Packing s/packet : 12149766.Packing machine f65 2023-05-11.Eto channel steris 2023-05-23.Final shop packet no: 12149775.Batch: 23e10g0e05.Article no : 4253540up0.Cam d393 2023-05-10.Cal d394 2023-05-10.Ecm d395 2023-05-10.Final shop packet no: 12149777.Batch: 23e11g0e01.Article no : 4253540up0.Cam d393 2023-05-10.Cal d394 2023-05-10.Ecm d395 2023-05-10.Final shop packet no: 12149776.Batch: 23e10g0e09.Article no : 4253540up0.Cam d393 2023-05-10.Cal d394 2023-05-10.Ecm d395 2023-05-10.Process cards show no abnormalities.Problem analysis: limited defect mode is described in the complaint description after translation which only stated, "accident exposure to blood, prick type with an intravenous catheter.The prick happened during the elimination of waste linked to this treatment.Incident declared ti authorities because the safety of the catheter was not fully triggered".Besides, there was no further information on the method of handling of the product.The actual sample was not available for evaluation and further investigation was not possible.As advised in ifu application, after a successful cannulation; before removing the steel needle, compress the vein distal to catheter tip to prevent spillage of blood.At the same time stabilize the catheter hub to prevent catheter dislodgement during needle removal.Withdraw needle straight back with a controlled and continuous motion (minimize rotation of needle).Metal safety shield will automatically attach to needle tip as needle tip exits catheter hub (see figure d).Dispose of needle immediately into sharps container.Process analysis: review on production process flow as below, cam & ecm machine has online vision system to conduct 100% checking on relevant critical dimension of cannula including crimp width, crimp length, clip dimension and clip position.All the defective parts will be automatically rejected by the machine.The in-line test equipment is also subject to frequent calibration and regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in-time and would be mitigated asap.Manufacturing control: all the products are subjected to in-process quality controls and final controls inspection on a random sample basis which has been conducted by different teams on a regular basis within the production process to ensure the product are free from any damages.Herewith a systematic product defect would be detected.Function test (manual) safety clip function: performed safety clip function (test method 109040) on products to inspect and test the assembled clip under adverse conditions to ensure the clip function ability (test only for safety version and applicable for all the gauges / sizes) place and hold the housing firmly on a table, while the other hand is to pull the needle with clip completely out of the housing.The needle clip must be blocked and to test this, push the needle on a stretched rubber glove and the crimped cannula tip position is to be adjusted perpendiculary 50mm.The needle tip must not puncture through the glove according to the specifications throughout the daily inspection process.Batch analysis: clip function test.Ø clip function specification: the needle clip must be blocked, and the needle tip must not puncture through the glove.Ø the complaint batch passed clip function test and showed no abnormalities.Summary of root cause analysis: as the affected sample was not provided, further evaluation is not possible.Hence the root cause could not be determined.Cause : cause could not be determine.This complaint is most likely not appeared to be attributed by the manufacturing process as the complaint sample is able to be detected and rejected by the 100% in-line vision systems of the equipment.All the products are manufactured in accordance to product specification - introcan safety® (rmf-120-010-ps-01) and conformed to the requirement of iso standard.All the product manufactured is subjected to and must be passed all the in-process and final control inspection.Dhr review showed no deviation at in-process and final control inspection.The actual sample and picture or not provided for further evaluation.Without the actual sample and picture, further evaluation was not possible, and the exact cause of the event could not be determined.Therefore, this complaint is concluded not confirmed.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: 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18771313
• MDR Text Key: 336176961
• Report Number: 9610825-2024-00102
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/03/2024

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: 4253540-01
• Device Lot Number: 23E10G8912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2023
• 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