MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY ® 2; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4242008-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the event description: when removing the venous catheter, the nurse noticed that the catheter was broken.A piece of the catheter was stuck in the vein.Reportedly there was significant difficulty in removing the piece of catheter remaining in the vein.The fragment was removed with clamp.
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 23g24g8273 and there were no defect encountered during in process and final control inspection.Sample evaluation: received one (1) pc of introcan safety 2 wl pur m 20gx32mm - eu without packaging.Observed the capillary had been broken off into 2 pieces.The tear off part pattern was a clean cut and the capillary was measured at around 28mm.As communicated in ifu, warning section stated that: do not re-use.Re-use of single-use devices creates a potential risk for 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 the 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patient and discard both.Never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter.Do not use scissors or sharp instruments at or near the insertion site.Reviewed assembly process: this product is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.Defective parts found out of the vision system criteria will be detected and rejected automatically.The process cards for the complaint batch show no abnormality.Conclusion: the returned sample was inspected and tear off capillary was observed.Batch analysis results show no such defect captured for the complaint batch.This defect is not due to manufacturing process.The tear off capillary shows a clean cut and is likely cut by a sharp tools.Complaint is not confirmed.We thank you for the opportunity to investigate and clarify this complaint.Should you need further clarification, please contact us for assistance.

• Brand Name: INTROCAN SAFETY ® 2
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 20728131
• Report Number: 9610825-2024-00828
• Device Sequence Number: 13009173
• Product Code: FOZ
• UDI-Device Identifier: 04046955746026
• UDI-Public: (01)04046955746026(11)230724(17)280701(10)23G24G8273
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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 Catalogue Number: 4242008-01
• Device Lot Number: 23G24G8273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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: Required Intervention
• Patient Sex: Unknown