MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY®; PUMP, INFUSION

Model Number 4253523-03

Device Problem Material Fragmentation (1261)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/13/2023

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in china: "capillary broken" according to the complainant, on the second day of infusion, the nurse found that the needle tube had broken inside the blood vessel.The patient underwent surgery and the broken tube was successfully removed.

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.Investigation results: device history record (dhr): reviewed the device history record for the reported batch number and there were no defect encountered during in process and final control inspection.Evidence at disposal: no sample received but a picture was provided for evaluation.The picture shows two samples of g24 introcan safety catheter hub.Sample 1: used capillary without capillary hub.Sample 2: an unused sample with complete parts.Reviewed assembly process: this product is assembled on automated assembly machines equipped with 100% vision system and test stations.The process cards for the complaint batch show no abnormalities.Manufacturing control: products are subjected to in-process quality controls and final controls inspection based on random samples 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.The process cards of the complaint batch show no abnormalities.Conclusion: tear off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and reject by the in-line vision system.Damages induced after assembly process.

• Brand Name: INTROCAN SAFETY®
• Type of Device: PUMP, INFUSION
• 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: 18330051
• MDR Text Key: 330521415
• Report Number: 9610825-2023-00581
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2023

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: 4253523-03
• Device Lot Number: 22M05G8921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention