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

Catalog Number	4251687-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: reason of complaint: introcan iv catheter 4251687-02 failed during therapy.Catheter broke off from hub upon removal; catheter piece remains inside patient and will be evaluated by a vasular surgeon today.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample attached to an extension set was submitted to the manufacturer for evaluation.It was noted that the broken off piece of the catheter was not received.Through visual examination, no damage on the capillary hub and capillary horn area were observed.No residue of capillary was observed at metal bush after dissecting the capillary hub that assumed the capillary had completely detached from the metal bush.A simulation at three catheter assembly lines (cal) which manufacture g18 products to replicate the reported issue was conducted.The metal bush and capillary insertion depth is monitored by the in-line vision system, which detects and automatically rejects any incomplete insertions.A simulation was conducted using 30 in-house samples with bush capillary depths greater than 3.3 mm, which fall outside the acceptance specifications.The objective was to investigate whether incomplete insertion of the metal bush and capillary could contribute to capillary detachment defects.The simulated samples were sent to ipqc for catheter strength testing; the results obtained noted that all samples passed the test.Based on the investigation, the reported issue was observed.However, an exact root cause could not be determined at this time.Training was conducted to operators to heighten their awareness of this issue.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY®
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: elena reifenstein ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 23878188
• Report Number: 9610825-2025-00736
• Device Sequence Number: 9622926
• Product Code: FOZ
• UDI-Device Identifier: 04046963165987
• UDI-Public: (01)04046963165987
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220626
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 4251687-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown