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

Model Number 4251342

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

Event Type  malfunction  

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.Manufacturing site evaluation: device history record (dhr): reviewed the device history record for batch number 23a08g8392 and there were no defect encountered during in process and final control inspection.Evidence at disposal: no sample were returned but hc-pm complaint team received 1 (one) customer picture of a used and contaminated introcan certo pur 18gx1 1/4", 1,3x32mm.From the picture provided, it can be observed that the capillary is tear off / damaged near the housing (refer to customer's picture).Based on the summary assessment from hc-pm, the definitive cause for the damaged capillary cannot be ruled out and therefore the complaint is considered as not confirmed.Complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample is returned, complaint will be re-opened accordingly.

Event Description

As reported by the user facility information by bbm sales organization in columbia: "broken catheter" according to the customer: when performing the venous access cannulation procedure peripheral with peripheral catheter number 18 in left folds canalizes vein achieving venous return, when removing the mandrel (needle) it is observed that the support for easy insertion of the catheter returns along with the needle and the catheter (plastic) remains in come to.,peripheral catheter data,ref (b)(4).,lot 23a08g8392,failure identified, on the technical and security side, everything was done correctly, but if repairs have been made to protect against defects in the catheters and supplies have not changed.

• Brand Name: INTROCAN® CERTO
• Type of Device: CATHETER,INTRAVASCULAR
• 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: 18278721
• MDR Text Key: 330114626
• Report Number: 9610825-2023-00559
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4251342
• Device Lot Number: 23A08G8392
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male