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

Model Number	4251601-020
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)."plastic part of canulla stay in the body." according to thr customer: "during extraction of the cannula temporoparietally on the left, an incomplete plastic flexible part of the cannula was pulled out - about 2cm broke off, remaining in the vein.Surgical extraction was performed without difficulty under sterile conditions, sterilstrip fixation, sterile cover.".
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.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Received 1pc used capillary hub of introcan-w fep 24gx3/4", 0,7x19mm without packaging.The sample was taken for investigation and observed the capillary tip was cut off approximately 5mm from the capillary hub horn area.The surface of the cut and the shape of this area leads to the assumption that this damage was caused by a sharp tool.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.Cut off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected during inspection process.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.The simulation by cannula reinsertion did not produce similar defect as per complaint sample.The complaint sample defect matches with the simulation sample of being cut by sharp object such as a scissors or scalpel.The defect on the complaint sample is believed to be occurred after the cannulation process due to been cut by a sharp tool.As communicated in ifu, warning section stated that: · after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Cause : defect due to wrong handling (referring to application error or off-label use).Reviewed the device history record for batch number 21e31g8392 and there were no defect encountered during in process and final control inspection.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®
• Common Device Name: I. V. CANNULAE
• 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: 13608332
• Report Number: 9610825-2022-00067
• Device Sequence Number: 19315299
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250401(10)20D26G8371
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2026
• Device Model Number: 4251601-020
• Device Catalogue Number: 4254074B
• Device Lot Number: 21E31G8392
• 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: 02/07/2022
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/26/2022
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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