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

Model Number	4251601-020
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/09/2023
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 bbm sales organization in taiwan: "needle stick injuries." "safety device activated but nurse still injured by the needle.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Device history record (dhr): reviewed the dhr of the complaint batch 22g10g8921 and no abnormality was observed during in-process and at final control inspection.Evidence at disposal: no sample was received and no photo available for a proper analysis.Limited information received where the situation described safety device activated but nurse still injured by the needle.Refer to instructions for use: as advised in ifu application, after a successful cannulation; before removing the steel needle, compress the vein distal to catheter tip to prevent spillage of blood.At the same time stabilize the catheter hub to prevent catheter dislodgement during needle removal.Withdraw needle straight back with a controlled and continuous motion (minimize rotation of needle).Metal safety shield will automatically attach to needle tip as needle tip exits catheter hub (see figure d).Dispose of needle immediately into sharps container.In the ifu as mentioned in the risks: this i.V.Catheter is designed to reduce the risk of accidental needlesticks; however, care must be taken to avoid needlesticks.Standard precautions must be adhered to in accordance with centers for disease control and prevention / occupational safety and health administration (cdc/ osha) standards.Reviewed assembly process: review on production process flow as below, cam & ecm machine has an online vision system to conduct 100% checking on relevant critical dimensions of the cannula including crimp width, crimp length, clip dimension, and clip position.All the defective parts will be automatically rejected by the machine.The in-line test equipment is also 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 asap.The process cards of the complaint batch show no abnormalities.Conclusion: as no sample was received for investigation, the actual cause could not be determined.The manufacturing batch shows no abnormality and ipqc and final control results show no deviation, hence, complaint is 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
• 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: 17078385
• Report Number: 9610825-2023-00236
• Device Sequence Number: 11297046
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 09/18/2023

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: 4251644-03
• Device Lot Number: 22G10G8921
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/07/2023
• Supplement Report FDA Received Date: 09/18/2023
• 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