MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number	4251128-02
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: event 5.Brief inquiry description iv catheter coming apart.Detailed inquiry description: per the account "the nurses have had issues with a certain lot # of the closed cath iv.There were i believe 4 that were used and i pulled the rest from shelf.I have 10 unopened that i pulled.They are coming apart, which in turn causes patients to bleed." based on investigation results on 06jan2025, five out of twelve returned samples were confirmed.Mdr 9610825-2025-00001 created to cover fifth received sample with confirmed defect.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Event 5: twelve (12) samples and two (2) photos were submitted to the manufacturer for evaluation.Through visual examination of the photos, photo one showed an is3 g22 sample in a dismantled condition.The catheter hub had detached into two pieces, the valve housing and septum opener were dislodged out from catheter hub.The safety clip was activated and engaged at the cannula tip.Photo two was a photo of the primary packaging of the introcan safety 3.Through visual examination of the twelve received samples, five samples were detached from the catheter hub.The reported defect is confirmed.A review of the device history record was performed for the reported lot number and no abnormalities or nonconformances were noted during the in process or final product inspection.The defect is a result of a failure in the production process and is a known issue.An approved project is in place to further address issues with catheter detachment.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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 21082659
• Report Number: 9610825-2025-00001
• Device Sequence Number: 20939374
• Product Code: FOZ
• UDI-Device Identifier: 04046964014017
• UDI-Public: (01)04046964014017(17)290601(10)24F09G8952
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K182870
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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: 4251128-02
• Device Lot Number: 24F09G8952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2024
• 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