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

Model Number	4251601-020
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
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 china: "blood leakage." "there was blood leakage at the connection between the hub and the catheter.".
Additional Manufacturer Narrative
This report has been identified as b.Braun internal report number (b)(4).Device history record (dhr): reviewed the device history record for batch number 22n01g8921 and there were no defect encountered during in process and final control inspection.Samples for evaluation: received 2 used and probably contaminated capillary hub of an introcan safety-w pur 24g, 0.7x19mm-ap without packaging.Cannula hub and protective cap were not being returned for investigation.Leakage test: samples were subjected to leakage test and both samples were found leaking from the plastic capillary.Samples were closely inspected at the leaking area.Result form sample 1: a cut was observed at the capillary at catheter hub horn.The cut observed is suspected to be a front cut caused by the reinsertion of cannula from the front bevel.The cut resembles of a v-cut shape.Result form sample 2: a cut was observed at the capillary near catheter hub horn.The cut observed is suspected to be a front cut caused by the reinsertion of cannula from the front bevel.Reviewed assembly process: this product is assembled on automated assembly machines equipped with vision system and test stations.Along the machines, there is catheter leakage test station which parts will go through 100% leakage test station using air pressure.Parts found leaking will be detected and rejected at eject reject part station.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.The process cards of the complaint batch shows no abnormality during the manufacturing.Review of ipqc inspection results: ipqc capillary surface, damages, air tightness 300 kpa/30 seconds (3 bar/30 seconds) 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 seconds.The results were reported as passed.Instruction for use (ifu) review under precautions & warnings: 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.Never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter.Extreme care should be taken not to damage, pierce, cut or sever the catheter.Therefore, do not bend the catheter and/or needle during insertion, advancement, or removal of the needle.Conclusion: based on the cut on the capillary, this defect is mostly likely to due application error.According to ifu, never reinsert the needle inside the catheter once the needle has been partially or completely withdrawn as it may pierce and/or sever the catheter.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: 17124924
• Report Number: 9610825-2023-00240
• Device Sequence Number: 12362335
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: 4253523-03
• Device Lot Number: 22N01G8921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/14/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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