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

Model Number 4252535-02

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2021

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the device involved in the reported event are being made.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported through mw (b)(4): registered nurse (rn) assessed the positioning of an introcan safety® iv catheter 20g x 1.25 fep (s) pt's on left hand near wrist of patient realizing that iv site not flushing.Rn removed this introcan safety® iv catheter 20g.The site of the patient's iv catheter 20g that was on left hand near wrist had a dressing that overlapped with another iv catheter 20g site dressing located on the left lower forearm.Resistance was not met when introcan safety® iv catheter 20g on left hand near wrist was removed.Iv catheter that was removed from patient was compared to an unused 20g iv catheter and measured by charge rn.It was found that 2 cm of the used iv catheter were missing.Orders were received for venous ultrasound of left extremity.Patient stated that pain on his left extremity is a 0/10 at this time.Original packaging had been discarded.Patient had radiology studies which showed the broken piece may be lodged higher in the venous system.Vascular consult done and surgeon recommended that the piece be left where it is.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).Failure analysis and investigation results did not confirm the reported issue.Upon receipt the used sample two simulations were performed.Scenario 1 - pierce by cannula a simulation was conducted by using a good part and piercing the capillary with cannula and later tear off the capillary.This defect is similar to cannula reinsertion where the cannula would pierce the capillary and cause it to be broken apart.The simulation sample was taken for inspection and observed that defect created was not similar to complaint sample.The capillary broken area exhibits a clear "v" shape cut from the cannula bevel.Scenario 2 - cut by scissors a good sample capillary was cut by scissors and take the sample for inspection.The defect created was similar to the complaint sample.The cut area exhibits even surface similar to the complaint sample.Conclusion: tear off capillary defect most likely not appear to be attributed by manufacturing process as the defect is able to be detected during inspection process.Damages induced after assembly process is not possible since the catheter had been protected with the protective cap.The simulation by cannula reinsertion did not produce similar defect as per complaint sample.The complaint sample defect matches with the simulation sample of being cut by sharp object such as a scissors or scalpel.The defect on the complaint sample is believed to be occurred after the cannulation process due to been cut by a sharp tool.As communicated in ifu, warning section stated that: · after withdrawal, do not reintroduce the steel needle into the catheter, as the latter may be cut off, leading to catheter embolism.Cause : defect due to wrong handling (referring to application error or off-label use) based on the results of the investigation, no conclusions can be made regarding the cause of the reported event.If additional information becomes available, a follow up report will be submitted.

• Brand Name: INTROCAN SAFETY®
• Type of Device: CATHETER,INTRAVASCULAR
• 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, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12067090
• MDR Text Key: 268034037
• Report Number: 9610825-2021-00244
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 04046963165925
• UDI-Public: (01)04046963165925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4252535-02
• Device Catalogue Number: 4252535-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2021
• 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
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 82 KG