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	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/12/2025
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: while placing the catheter, the iv needle was partially pulled back and then reinserted.Needle appears separated/ split from the catheter itself.Detailed inquiry description: product code: 4251128-02 expiration date: 1/1/30 lot number: 25a04g8952.Patient was involved but customer has not gotten back with patient information to file.Description of the patient event: iv placed, minimal flash seen in chamber, attempted to continue placement, client complained of pain, iv removed, catheter seen split (appeared to be intact otherwise/no pieces missing).
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400711195.One (1) photo was submitted to the manufacturer for evaluation.Through visual examination of the photo, the capillary of the sample was observed to be pierced by the cannula (needle).Blood was observed on the capillary, meaning the capillary had been used.This indicates that the product did not pierce during the manufacturing process or else it could not be used by the user.No needle breakage was observed.A review of the device history record (dhr) 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 line is assembled on automatic assembly machines equipped with 100% vision inspection system and test stations.Along the machines, there is 100% inspection on the condition of the catheter tip.Parts found out of the inspection criteria will be detected and be rejected by machine automatically.The process cards shows no abnormalities for the complaint batch.Based on the investigation, the reinsertion occurred during production application.This defect is not due toa manufacturing process issue.The complaint is considered not 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® 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: 22125746
• Report Number: 9610825-2025-00314
• Device Sequence Number: 21002346
• Product Code: FOZ
• UDI-Device Identifier: 04046964014017
• UDI-Public: (01)04046964014017(17)300101(10)25A04G8952
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K111236
• 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): 06/13/2025

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: 25A04G8952
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2025
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 84 KG