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

Model Number 4253523-03

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/10/2024

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.Bmi complaint management dated 2024-01-11.Device history record (dhr): reviewed the device history record for batch number 23b15g8316 and there were no defect encountered during in process and final control inspection.Sample receipt at bmi - complaint investigator, dated 2024-01-23.Bmi preliminary investigation:- received 1 used and contaminated capillary hub of an introcan safety-w pur 24g, 0.7x19mm-ap in an opened packaging.Lot number printed on returned peel pack was 23b15g8316 and material# 4251644-01.Attached with the returned sample was an extension set, presumably used with the product.Cannula hub and protective cap were not being returned for investigation.Based on test spec #: hc-my01-m-5-4-10-027-0 (introcan sterile), took the sample to a visual test according to test method 102000 (visual) | test method 102002 (damages), observed that the capillary was detached and the broken off capillary is being attached to the extension set.Root cause analysis: process cards show no abnormalities.Trend analysis: customer complaint of capillary / damage - tear off for introcan safety trend analysis is being tracked based on capa initiation criteria.Sample received: received 1pcs contaminated capillary hub of introcan safety-w pur 24g, 0.7x19mm-ap in an opened packaging from batch 23b15g8316 and material# 4251644-01.Also being returned for investigation was the broken off capillary piece and an extension set presumably used with the product.The cannula hub and protective cap were not being returned for investigation.Simulation on capillary detached: · simulation was performed on fresh introcan safety g24 samples to simulate for complaint defect.· the capillary of fresh introcan safety g24 was twisted while pulling apart to reproduce similar capillary elongation before fully break apart.· the simulated sample was then inspected under keyence microscope and compared with returned complaint sample.· observed similar defects between simulated sample and complaint sample (in blue circle) especially on the capillary elongation and thinning effect at capillary remnant at metal bush, and similar capillary break point at broken off capillary, refer photos comparison below.· from the simulation, the capillary detached could be possibly due to improper handling after insertion into vein whereby external forces applied to pull and break the capillary.Review of process card: · the complaint batch was produced at braun 3 introcan line 8.· process cards for assembly machines above were reviewed.No abnormality observed.Review of assembly process flow: introcan catheter assembly line (cal).In cal, all assembled part would go through catheter leakage test station (as highlighted in yellow) to check the assembled parts.Parts with catheter hub leakage will be automatically rejected and removed at the eject reject part station.Therefore, the defective unit will not proceed to the next process.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.Review of final control inspection results: test specification: introcan sterile (hc-my01-m-5-4-10-027-0).· final control visual inspection and functional test results for batch 23b15g8316 were reviewed.· the inspection results were reported as passed.Review of ipqc inspection results · ipqc inspection results on catheter strength test, capillary surface, damages, assembly defect, air tightness 300 kpa/30 s (3 bar/30 s) of vein catheter (capillary), between catheter (capillary) and catheter hub (incl.Inner taper of hub) and high pressure test 300 psi (20.7 bar) for 10 s test results for assembly shop packets 12134763 and 12134960 were reviewed.The results were reported as passed.· ipqc and final control holdback record was reviewed.No damage or functional related holdback reported for complaint batch 23b15g8316.Instruction for use (ifu) review: this product is recommended to be used as explained in instruction for use (ifu).Warning: · after withdrawal, do not reintroduce the steel needle into the catheter, as the later may be cut off, leading to catheter embolism.· do not bend the catheter/needle during insertion, advancement or removal of the needle.Extreme care should be taken not to cut the catheter and possibly cause an embolism.Summary of root cause analysis: · received 1pcs contaminated capillary hub of introcan safety-w pur 24g, 0.7x19mm-ap in an opened packaging from batch 23b15g8316 and material# 4251644-01.Also being returned for investigation was the broken off capillary piece and an extension set presumably used with the product.The cannula hub and protective cap were not being returned for investigation.· multiple damages were observed on returned broken capillary and catheter hub.· from the simulation, the capillary detached could be possibly due to improper handling whereby external forces applied to pull and break the capillary.· process cards were reviewed.No abnormality during manufacturing of the complaint batch 23b15g8316.· process flow was reviewed.In cal, all assembled part would go through catheter leakage test station to check the assembled parts.Parts with catheter hub and valve leakage will be automatically rejected and removed at the eject reject part station.Therefore, the defective unit will not proceed to the next process.· final control and ipqc visual inspection and functional test results was reviewed for batch 23b15g8316.All results were reported as passed.· this complaint is concluded as not confirmed.Cause : cause could not be determine.Complaint returned sample was investigated at bmi and observed multiple defects.From the simulation, the capillary detached could be possibly due to improper handling after insertion into vein whereby external forces applied to pull and break the capillary.Review of dhr and final control inspection showed no deviation.This complaint is concluded as not confirmed.Corrections/containment plans with effective date: not applicable.Corrective actions with effective date: not applicable.Justification: not confirmed.

Event Description

As reported by the user facility information by bbm sales organization in china: capillary detached".According to the customer: "during the morning ward round, the nurse found that both the needle and connector on the child's arm had fallen off, but there was no capillary on top of the needle.The nurse carefully searched and found the broken capillary on the bed.".

• Brand Name: INTROCAN SAFETY®
• 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: 18675152
• MDR Text Key: 335945255
• Report Number: 9610825-2024-00070
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/09/2024

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 Model Number: 4253523-03
• Device Lot Number: 23B15G8316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1