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

Model Number	4251628-01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Extravasation (1842); Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event description: the nurse report catheter fragmentation after inspection with catheter removal due to extravasation.Total catheter fragment migration through veins is currently under evaluation.Written report does not describe surgical removal or percutaneous extraction.Verbal reports indicate failed surgical removal attempt.Official report from customer and sales rep verbal report attached.
Additional 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.Device history record (dhr): reviewed the device history record for batch number 24e12g8362 and there were no defect encountered during in process and final control inspection.Samples for evaluation: received 8 (eight) unused of introcan safety pur 22g, 0.9x25mm-eu and in original packaging.Lot number printed on returned peel pack are 24e12g8362 and material # 4251628-01.The actual reported complaint sample was not returned.Visual inspection: these samples were taken for investigation and observed the capillary does not exhibit any damages and no tear off capillaries.Complaint description: the situation described that a nurse reported catheter fragmentation after inspection with catheter removal due to extravasation.As communicated in ifu, warning section stated that: - do not re-use.Re-use of single-use devices creates a potential risk of patient or user.It may lead to contamination and/or impairment of functional capability.Contamination and/or limited functionality of the device may lead to injury, illness or death of the patient - in the case of an unsuccessful iv catheter placement attempt, remove the needle first to activate safety mechanism, then remove catheter from patient and discard both.Never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter.- extreme care should be taken not to damage, pierce, cut or sever the catheter.Therefore, do not bend the catheter and/or needle during insertion, advancement, or removal of the needle.- do not use scissors or sharp instruments at or near the insertion site.Reviewed assembly process: this product is assembled on automated assembly machines equipped with 100% vision system and test stations.The tear-off capillary defect is unlikely to have been caused by the manufacturing process because it can be detected by the vision system and be rejected automatically.The in-line test equipment is 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.The process cards for the complaint batch show no abnormality during the manufacturing process.Manufacturing control: besides the in-line test equipment, products are subjected to in-process and final control inspection based on random samples basis.Herewith, a systematic defect can be detected.The complaint batch shows the inspection result as passed.Conclusion: the returned samples found no defect or any abnormality.Complaint is not confirmed.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: 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: 20576634
• Report Number: 9610825-2024-00782
• Device Sequence Number: 8095343
• Product Code: FOZ
• UDI-Device Identifier: 04046963166021
• UDI-Public: (01)04046963166021(11)240512(17)290501(10)24E12G8362
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 4251628-01
• Device Lot Number: 24E12G8362
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown