MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN® SAFETY 3; I.V. SAFETY CATHETER,

Model Number	4251130-01X
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are available.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.
Event or Problem Description
As reported by the user facility information by bbm sales organization in belgium: "pur was broken off" according to the customer: "the customer removed the catheter from the hand back a patient and found that a piece was missing at the tip of the "tube" (pur was broken off on approximately +/- 1cm - see attached picture).The missing part is probably still inside the patient.An ultrasound was performed immediately but nothing could be seen.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).We received two used capillary housing of an introcan safety 3 pur 20g 1.1x32mm-eu without packaging and two introcan safety 3 pur 20g 1.1x32mm-eu in original packaging.Furthermore, we received one customer picture of the complained samples.The following investigations were conducted: visual inspection: the received samples were taken to a visual inspection for damages according to the test method for damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G., the impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: at one used sample the capillary is damaged / cut off approximately 18 mm away from the capillary housing.The surface of the cut leads to the assumption that this damage is caused by scissors.At the other 3 received samples we detected no damage.Summary and assessment: relating to the cut of capillary at the sample, we assume of a handling error.Based on the conducted investigations the tested samples are within the specification.Therefore, the complaint is considered as not confirmed.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 3
• Common Device Name: I.V. SAFETY CATHETER,
• 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: 17685141
• Report Number: 9610825-2023-00413
• Device Sequence Number: 17703854
• Product Code: FOZ
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2023

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 Model Number: 4251130-01X
• Device Lot Number: 23B25G8934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 08/07/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 11/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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
• Patient Sex: Unknown