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

Catalog Number 4253604-03

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4), as no sample and no meaningful picture was provided, proper investigation on malfunction could not be performed.Device history record (dhr): reviewed the device history record for batch number 21f28g8271 and there was no defect encountered during in process and final control inspection.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 Description

As reported by the user facility (translation of user facility information by bbm sales organization in china: "tube broken." according to the customer: "the patient was in normal condition during use.When the nurse pulled out the needle after the infusion treatment, found that part of tube was in the patient's body.The department cooperated with the vascular surgery consultation to remove the remaining tube from the patient's blood vessels.".

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 21f28g8271 and there were no defect encountered during in process and final control inspection.Sample evaluation: received 1 used and contaminated introcan safety-w pur 18g, 1.3x32mm-ap without packaging.Visual inspection observed the capillary was cut off near the capillary hub horn.The cut off area was a straight and clean cut from both torn off capillary sides.Root cause: based on the investigation above, this defect is believed to be caused by sharp tools because the cut was clean and straight as per simulation sample.Reviewed assembly process: this product line is assembled on automatic assembly machines equipped with vision system and test stations.Tear off capillary most likely not appear to be attributed by manufacturing process as the defect is able to be detected and reject by the in-line vision system.Damages induced after assembly process is not possible since the catheter had been protected with protective cap.Conclusion: this defect is due to application error as this cannot happened as assembly site.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-W FEP
• Type of Device: 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: 15859449
• MDR Text Key: 304275793
• Report Number: 9610825-2022-00492
• Device Sequence Number: 1
• Product Code: DQR
• UDI-Device Identifier: 04046964478673
• UDI-Public: (01)04046964478673(17)250501(10)20E06G8911
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K982805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4253604-03
• Device Lot Number: 21F28G8271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1