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

Model Number 4253566-01

Device Problem Difficult to Insert (1316)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2023

Event Type  Injury  

Event Description

As reported by the user facility information by bbm sales organization in italy: "block safety system during use." according to the complainant during the procedure of insertion of the needle in the vein, there was difficulty in the extraction of the metal needle from the silicone component of the device.The operator assumed there was a block of the security system of the needle which caused the metallic needle release still inserted in the silicone component which resulted bent and pierced from the same needle.The abnormal release of the unprotected needle (exposed sharp tip) caused the accidental puncture of the operator who performed the maneuver.It is confirmed that the insertion operation, as per clinical practice, took place in a single operation and that the operator made no attempts at repositioning.Operator and patient underwent blood tests to exclude any risk of transmission of infectious diseases.

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.Summary and assessment: as no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.The investigation sample(s) is/are not available.Bmi complaint management dated 2023-12-21 device history record (dhr): reviewed the device history record for batch number 22l22g8361 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no samples returned and no photos provided for this notification.Further evaluation and investigation cannot be concluded.This complaint however, shall 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.Process cards show no abnormalities problem analysis limited defect mode was described in the complaint description which states "it was detected difficulty in the extraction of the metal needle from the silicone component of the device, assuming a block of the security system of the needle which caused the metallic needle release still inserted in the silicone component".There was no further description of the method of handling the product.Sample or photo was not provided in the complaint.Therefore, further investigation was not possible.Process analysis the possible cause that might affect the withdrawal force is the siliconisation station.The station is highlighted in below[?]process flow.Process flow cam process flow ecm process mapping of end control machine (ecm) and cannula assembly machine (cam) for introcan safety has been reviewed.There is an in-line test (its) checking for cam at applying siliconizing station to ensure the presence of silicon oil in the product and its concentration is within the specification.The in-line test equipment is subject to frequent calibration and regular verification related to its proper function.[?]therefore, a systematic product defect would be detected.On the other hand, ecm consists of an auto wiping station which will help to minimize the high withdrawal force of introcan safety products and make sure the withdrawal force of the product is within the specification.Besides, cam & ecm machine has an online vision system to conduct 100% checking on a relevant critical dimension of a 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.Batch analysis · ipqc result was reviewed, no abnormalities were found.· criteria for damages and withdrawal force was accepted with 0 defects or failure from the inspection.Summary of root cause analysis: as the affected sample and photo were not provided, further evaluation is not possible.Hence the root cause could not be determined.Cause : cause could not be determined withdrawal force defects do not appear attributed by the manufacturing process as the defective sample can be detected and rejected before it is passed to the next process.All the product manufactured is subjected to and must pass all the in-process and final control inspection.Herewith a systematic product defect would be detected.All the products are manufactured in accordance with product specification - introcan safety® (rmf-120-001-ps-01) and conform to the requirement of iso standard.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).The following investigations were conducted: visual inspection: no sample was received and thus a further evaluation and investigation of the complaint is not possible.Functional inspection: n.A.Physical inspection: n.A.Summary and assessment: as no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.The investigation sample(s) is/are not available.Bmi complaint management dated 2023-12-21 device history record (dhr): reviewed the device history record for batch number 22l22g8361 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no samples returned and no photos provided for this notification.Further evaluation and investigation cannot be concluded.This complaint however, shall 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: 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: 18494132
• MDR Text Key: 332676799
• Report Number: 9610825-2023-00681
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/21/2024

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: 4253566-01
• Device Lot Number: 22L22G8361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2022
• 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