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

Model Number	4251601-020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Received two pictures from the customer of the complained introcan safety 3 pur 18g 1.3x32mm-sa.As the affected sample was not provided and the pictures received were poor quality, proper visual assessment on the pictures was unable to be done.Unable to review the device history record for batch number 21l06g892 as the batch number provided does not exist in sap mya, further evaluation is not possible and the exact cause of the failure could not be determined.The in-line test equipment is subject of a frequent calibration and a regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in-time and would be mitigated.Beside the automated 100% in-line test equipment, independent in-process quality controls and final controls on a random sample basis will be conducted by different teams on a regular basis within the production process.Herewith a systematic product defect would be detected.Tear off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.Cause : defect due to wrong handling (referring to application error or off-label use) justification: 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.
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in colombia: "broken device." "patient who consulted a health institution for abdominal pain on (b)(6) 2022, who was given an intravenous catheter for medication.The catheter is removed from the patient for discharge.Patient re-consults for pain at the catheter insertion site and poor mobility.The patient reported "i feel like i'm squeezing".With ultrasound the attending physician identifies intramuscular foreign body with thrombosis and requires referral to a vascular physician for foreign body removal.".

• 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 18109
• MDR Report Key: 16018952
• Report Number: 9610825-2020-00541
• Device Sequence Number: 5896596
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 12/20/2022

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 Model Number: 4251601-020
• Device Catalogue Number: 4251131-04
• Device Lot Number: 21L06G892
• 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: 11/25/2022
• Initial Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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