MAUDE Adverse Event Report: B BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	4251128-01
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the event descritption: the details are as follows: staff removed cannula of patient post recovering from endoscopic procedures.When disposing the used cannula, she accidentally pricked herself, needle still intact inside the cannula catheter.Advised staff to clean the wound.Advised staff to go to a&e - refused.Patient records were checked for any infectious diseases - non found.Patient was asked if she has history of any infectious diseases - none reported.Staff advised that if feel unwell to bring herself to a&e.
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).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.Device history record (dhr): reviewed the dhr of the complaint batch 24g24g8953 and no abnormality observed during in-process and at final control inspection.Investigation statement: no sample received but two photos were provided.Picture 1: showed a duplex box of introcan safety 3 pur 22g 0.9x25mm-eu with language label from article 4251128-01 and batch 24g24g8953.Picture 2: observed an introcan safety 3 (g22) is attached to an extension set.The is3 was lined with a piece of paper towel and indicating wetness on the paper towel.Further evaluation and investigation cannot be concluded as it does not reflect on the actual defect which is clip failure.It is noticeable that the cannula remained inside the catheter hub and was not withdrawn out, thus no activation of the passive safety clip.This aligns with complaint description of "needle still intact inside the cannula catheter".Instruction for use (ifu) review as per reference to the instruction for use (ifu) for introcan safety 3 products, under precautions & warnings section: in the case of an unsuccessful iv catheter placement attempt, remove the needle first to activate safety mechanism, then remove catheter from patient and discard both.In the unlikely event that the safety mechanism has not been triggered/activated, keep the tip of the needle away from the body and fingers at all times and immediately dispose the iv catheter into a suitable sharp-proof container.Care must be taken to avoid needlestick injuries.Under application section: gently press the stabilization platform to the skin to stabilize the catheter (see figure d).Withdraw the needle straight out with a controlled and continuous motion (minimize rotation or bending of the needle).The metal safety shield will automatically attach to the needle tip as the needle tip exits the catheter hub (see figure e).Blood flow from catheter hub is restricted after needle is removed.Dispose of the shielded needle immediately into a sharps-proof container.Immediately connect the infusion line or accessory device and cover the puncture site with a sterile and transparent dressing per institutional protocol.Reviewed assembly process: this product is assembled on automated assembly machines equipped with 100% vision system and test stations.The assembly process cards was reviewed and no abnormality was observed for the complaint batch.Conclusion: as no sample was received, further investigation was not possible.The complaint batch show no abnormality, hence, complaint is not confirmed.

• Brand Name: INTROCAN SAFETY® 3
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21167761
• Report Number: 9610825-2024-01050
• Device Sequence Number: 4275850
• Product Code: FOZ
• UDI-Device Identifier: 04046964014017
• UDI-Public: (01)04046964014017(11)240724(17)290701(10)24G24G8953
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/16/2025

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: 4251128-01
• Device Lot Number: 24G24G8953
• 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: 12/17/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2024
• 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