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

Catalog Number	4252520-02
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
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: reporter called to report - safety mechanism didn't engage and broke off into the catheter hub.Remained in the catheter hub.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) sample was submitted to the manufacturer for evaluation.It should be noted that only the safety clip and catheter hub was returned; the cannula hub and protective cap were not returned for investigation.The safety clip was inspection, and no damages was observed.The clip hold was measured, and it falls within the specification of g20.Based on the inspection result, it is suspected that the returned sample's safety clip may have been mixed between g20 and g22 safety clips.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.Based on the investigation, the reported defect is confirmed.A possible root cause is the piece of complaint sample with g20 safety clip might have been accidentally collected by the operator and assembled it.However, it is confined to only one single piece with the fact that there ware tracking records of line clearance in place before the conversion of batches.Corrective actions include redesign a metal container to address the issue of clip stuck together that lead to operators placing small quantities of safety clips on the machine workstation, provided a magnetic rod for all crimping machines to collect dropped parts inside the machine and to revise the manual line clearance checklist to specify key areas to focus on during line clearance.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®
• 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: 19639102
• Report Number: 9610825-2024-00541
• Device Sequence Number: 12960185
• Product Code: FOZ
• UDI-Device Identifier: 04046963318178
• UDI-Public: (01)04046963318178
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K020785
• 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
• Report Date (Section B): 09/12/2024

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: 4252520-02
• Device Lot Number: 23M21G8243
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• 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