MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER, INTRAVASCULAR, THE,

Catalog Number 4251128-02

Device Problem Fail-Safe Problem (2936)

Patient Problem Skin Tears (2516)

Event Date 01/04/2024

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: concern description: another instance of this products inferiority is when i pulled the need to engage the safety mechanism and the mechanism got hung up in the hub of the catheter and pulled the catheter out halfway, because of this i almost lost the iv.I've been an rn for 10 years and have placed countless ivs.I've never almost lost an iv because the needle didn't disengage correctly.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number: (b)(4).One (1) used and contaminated sample connected to an extension set was submitted to the manufacturer for evaluation.It was noted that the protective cap and cannula hub were not returned.Through microscopic visual examination, a slight kink was observed at the capillary near the horn area.No damages were noted at the valve and valve opener; the valve was in a closed condition.No abnormalities at the catheter hub luer area were observed.A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformance's were noted during the in process or final product inspection.A simulation was carried out by manually assembling the returned catheter hub with a fresh sample of g22 cannula and protective cap.The protective cap was able to be removed easily with a slight push.Thereafter, the cannula was withdrawn, and the safety clip was able to engage successfully and completely cover the cannula tip.A simulation to check the valve function whereby the returned sample was assembled with a g22 cannula hub.A liquid tightness valve disk test was conducted; the returned catheter hub passed the test as no red dye solution was observed to leak out form the catheter hub during cannula withdrawal and after cannula withdrawal.The returned sample was then subjected to more testing, one with the sample connected to a b.Braun infusomat extension line and flushed with saline and one with the sample connected to a syringe and flushed with saline.The returned sample passed the test as no leakage was observed from the catheter hub.This product is assembled on an automated assembly machine equipped with 100% vision system and test stations.The in-line test equipment is subject to frequent calibration and regular verification related to its proper function.Herewith potential malfunctions of the systems would be detected in time and would be mitigated as soon as possible.Reviewed the process cards of the complaint batch and it shows no abnormalities.Based on the investigation, the sample was tested and passed the visual and leakage tests.The slight kink at the capillary near the horn is due to being used and is not a manufacturing defect.The reported defect is not confirmed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INTROCAN SAFETY® 3
• Type of Device: CATHETER, INTRAVASCULAR, THE,
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18502640
• MDR Text Key: 332772424
• Report Number: 9610825-2024-00006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 4251128-02
• Device Lot Number: 23H12G8951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2024
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/04/2024; 01/04/2024
• Supplement Dates FDA Received: 02/06/2024; 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2023
• 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