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

Model Number	4252560-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.
Event or Problem Description
As reported by the user facility: medwatch form received to medical affairs on 21dec2021.Braun introcan intravenous catheter 18 gauge inserted left forearm [date encrypted].Patient discharged on [date encrypted] 2021.Patient presented on [date encrypted] 2021 at 17:29 with left forearm pain and swelling, no drainage, no induration.Or abscess.Patient was afebrile, no rash, and no adenopathy.On [date encrypted] 2021: occlusive superficial venous thrombosis in the superficial vein of the left forearm associated with the venous catheter.No deep vein thrombosis noted.On [date encrypted]: no deep vein thrombosis seen.Superficial venous thrombus is present.Artifact within the thrombus suggesting a retained catheter may represent casting artifact.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical, inc.Internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.
Event or Problem Description
As reported by the user facility: medwatch form received to medical affairs on 21dec2021.Braun introcan intravenous catheter 18 gauge inserted left forearm [date encrypted].Patient discharged on [date encrypted] 2021.Patient presented on [date encrypted] 2021 at 17:29 with left forearm pain and swelling, no drainage, no induration.Or abscess.Patient was afebrile, no rash, and no adenopathy.On [date encrypted] 2021: occlusive superficial venous thrombosis in the superficial vein of the left forearm associated with the venous catheter.No deep vein thrombosis noted.On [date encrypted]: no deep vein thrombosis seen.Superficial venous thrombus is present.Artifact within the thrombus suggesting a retained catheter may represent casting artifact.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.Review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.  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
• Manufacturer (Section D): B.BRAUN MELSUNGEN AG; carl- braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B.BRAUN MELSUNGEN AG; carl-braun strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13228783
• Report Number: 9610825-2021-00571
• Device Sequence Number: 4074324
• Product Code: FOZ
• UDI-Device Identifier: 04046963165901
• UDI-Public: (01)04046963165901
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2022

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 Expiration Date: 12/01/2025
• Device Model Number: 4252560-02
• Device Catalogue Number: 4252560-02
• Device Lot Number: 20N17G8273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Unknown