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

Model Number	4251601-020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).The complaint is under evaluation.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 (translation of user facility information by (b)(6)organization in france: "catheter-leakage." according to the customer: "catheter leakage at the junction between the hub and the cannula.The leak was detected during administration.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).We received 2 used capillary housing of introcan safety 3 pur 18g 1.3x32mm-eu in open packaging.At one used sample, the capillary is completely punctured around the connection capillary / capillary hub.Furthermore, the capillary hub is deformed.At the second capillary housing we detected no damages.By ruling out all the possibilities, the only possible cause to induce this defect is at ecm machine at catheter to cannula assembly station if the catheter hub not sitting properly during insertion into the pallet that causing it to locate higher during gripper pickup.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
• 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 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17261209
• Report Number: 9610825-2023-00304
• Device Sequence Number: 12239980
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982805
• 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): 09/19/2023

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: 4251601-020
• Device Catalogue Number: 4251131-01
• Device Lot Number: 22K13G8373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/19/2023
• 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