MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY ® 2; CATHETER, INTRAVASCULAR, THE

Catalog Number	4232006-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported by the user facility: brief inquiry description defective iv catheters detailed inquiry description clinicians noted on the iv catheters that there is a "coating" on it.Was described as "waxy" or a "film" on the catheter.Others described as a "ball" like substance appearing on the catheters.Some noted the coating before placing the iv.Others were noted when placed in the patients.Some clinicians stated that when the catheter was threaded into the patient, the coating gathered at the site of insertion.Description of the patient event when threading the iv catheter, the clinician noted the film substance gathering at the insertion site of the catheter.As if the film was coming off the catheter when it was inserted and was gathering at the insertion site.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One sample was submitted to the manufacturer for evaluation.Through visual examination under 20x magnification using a keyence scope on the capillary surface of the received sample, no abnormalities were observed.No foreign material was observed.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.This product is assembled on an automated assembly machine equipped with vision systems and test stations.Silicone oil is applied on the external capillary surface during siliconization process, and this is to facilitate smooth capillary insertion process.The process cards of the complaint batch show no abnormalities.Based on the investigation, the sample is within specification and the defect could not 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.
Additional Manufacturer Narrative
Additional information/evaluation: this report has been identified as b.Braun medical internal report number (b)(6).One sample was submitted to the manufacturer for evaluation.Through visual examination under 20x magnification using a keyence scope on the capillary surface fo the received sample, no abnormalities were observed.No foreign material was observed.Two photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, it was observed that the photos are of the product introcan safety 2 wl pur m 20gx25mm - us (catalog # 4242006-02).Due to this, it was determined that the photos do not correspond with the reported products from complaints (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.This product is assembled on an automated assembly machine equipped with vision systems and test stations.Silicone oil is applied on the external capillary surface during siliconization process, and this is to facilitate smooth capillary insertion process.The process cards of the complaint batch show no abnormalities.Based on the investigation, the samples are within specification and the defect could not 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.

• Brand Name: INTROCAN SAFETY ® 2
• Common Device Name: 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: 18518422
• Report Number: 9610825-2024-00004
• Device Sequence Number: 6751319
• Product Code: FOZ
• UDI-Device Identifier: 04046955341894
• UDI-Public: (01)04046955341894
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 4232006-02
• Device Lot Number: 23A04G8274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024; 01/03/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/02/2024; 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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